how to get a clinical research certificate

ACRP Learning Update

ACRP is happy to announce forthcoming updates to several courses in the ACRP catalog.

CCRC Certification

Ccrc® (certified clinical research coordinator) is a credential formally recognizing clinical research professionals with experience coordinating and facilitating clinical trial activities in adherence to gcp, under the direction of a principal investigator., this trusted mark of excellence in clinical research is awarded to clinical researchers who have demonstrated proficiency of specific knowledge and skills by passing the standardized ccrc® certification exam., read the latest acrp ccrc® blog, “‘other duties as assigned’: the wide-ranging role of the crc professional” >.

Clinical research professional with 3,000 hours of verifiable work experience are eligible to sit for the CCRC ® Exam. Complete eligibility criteria is defined in the Academy’s  policy manual .

What qualifies as work experience, work related to human subject research, paid contractual agreement – employer/employee, can be verified by acrp through employer, what is excluded from work experience, any work that is part of a degree track or education program, any experience older than ten years, internships paid or unpaid.

APPLY FOR YOUR EXAM

ACRP may grant one experience waiver amounting to 1,500 hours of work experience to applicants who meet one of the following criteria:

Hold an active acrp certification, have successfully completed a clinical research education program*  , what qualifies as a clinical research education program*, must be aligned with the topics found in the corresponding exam content outline (eco), must have a valid third-party accreditation, must provide applicants with knowledge that is equivalent to 1,500 hours of knowledge earned through employment, *program approval is at the discretion of acrp and will not be reviewed or pre-approved outside of a paid application..

The CCRC ® exam consists of 125 multiple choice questions that must be answered within 180 minutes.

The exam is referenced only to the international conference on harmonization (ich) guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)., the global ccrc ®  exam committee uses psychometrically sound practices to develop certified clinical research coordinator (ccrc) examinations that meet the current test specifications as determined by the most recent job task analysis (jta)., the following are the only references for which the ccrc ® certification exam content can be supported:, ccrc ® exam content outline >, guideline for good clinical practice e6 (r2) >, definitions and standards for expedited reporting (e2a) >, general considerations for clinical trials e8 (r1) >, statistical principles for clinical trials e9, statistical principles for clinical trials e9 (r1) >, clinical trials in pediatric population e11 (r1) >, the declaration of helsinki (doh) >.

Review the Exam Content Outline and make sure your experience and work hours are appropriate, as outlined in the Eligibility tab.

We also strongly encourage you to review the entire acrp certification handbook , which provides full details about every facet of acrp certification..

Create a free ACRP account so you can begin the application process. Follow the on-screen prompts to enter any requested information and documentation.

If you already have an acrp account, please proceed to step three., create account >.

You’re almost there! Please note, applications selected for audit will undergo a formal review by ACRP’s subject matter experts. In most instances, you will receive a status update about your application within 10 business days.

In accordance with the americans with disabilities act, acrp will provide reasonable accommodations for candidates with disabilities. please complete this special accommodations form for submission with your application before proceeding..

Apply for Your Exam

The best way to prepare for the CCRC ® exam is to fully understand the scope of the exam content and its references.

Acrp offers a variety of training and continuing education programs focused on the key ich guidelines covered in the ccrc ®  exam., learn more >.

Find Test Centers Near You >

Schedule your in-person exam >.

Schedule Your Remote Exam >

Check system requirements >.

Exam results are shared immediately at the conclusion of your exam, but PSI will send you an email with your full score report within 24 hours.

Your acrp account will reflect your results within 24 hours..

Congratulations! You just passed a major milestone on your professional journey and are now a member of the elite club of ACRP Certified clinical research professionals.

Keep an eye on your email because you will soon receive information from our digital badging partner credly about claiming your digital badge and how you can use it to tout your accomplishment. also learn how to use your new credential by reviewing the  certification mark policy ., you have 2 years to keep your certification in good standing by continuing your professional development, and we’ll be right there with you every step of the way. in the meantime, we highly recommend you review all the details about maintenance of certification . don’t leave it to the last minute.

Don’t worry. It happens to the best of us. Give it another try!

Refer to your acrp certification examination results email or the acrp certification handbook  for guidance on the next steps in your certification journey., upcoming testing dates, spring 2025 testing february 15 – may 15, 2025, fall 2025 testing july 15 – october 15, 2025, registration dates and fees, early bird registration acrp members – $435 nonmembers – $485 spring 2025: october 21 – december 31, 2024 fall 2025: may 15 – july 15, 2025, regular registration acrp members – $460 nonmembers – $600 spring 2025: january 1 – april 30 fall 2025: july 16 – september 30, join acrp & save, joining acrp helps you save money. more importantly, acrp is where you will find the very best of what you need to design a career path that’s uniquely your own. connections through an engaged community. growth through gold-standard training. and elevation through rigorous certification., explore membership >, exam preparation, congratulations on your decision to earn the most recognized and respected endorsement of clinical research competency — acrp certification. as you start this important journey in your career, we’re here to support you every step of the way..

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Career guides, interviews & features, clinical research certification - ccra, ccrc, cpi, search for schools.

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Gaining a clinical research certification can offer many benefits for those in the field. Earning a credential through a rigorous application review and test indicates to potential employers that the holder boasts specific experience and skills making him or her more likely to succeed in a given occupation.

In the case of clinical research, this is especially important since running clinical trials requires hands-on training and continued guidance to ensure compliance with long-established standards.

These clinical research professionals include varied roles, including clinical research associates (CRA), clinical research coordinators (CRC), and principal investigators (PI).

In sum, having a certification in one of these areas can provide the following advantages:

Enhances Professionalism – Certified clinical researchers and investigators can take their career to a more professional level by:

• Becoming well-grounded in a core body of knowledge defined by the certifying body
• Committing to the pursuit of knowledge in their area of expertise through ongoing professional development
• Gaining certification through assessment signifying they possess the knowledge and skills necessary to lead in their field
• Committing to follow a code of ethics as defined by the certifying body

Indicates Competence – Through certification, an applicant’s knowledge and skills as a qualified, ethical clinical researcher are validated by a third party. Certification verifies an understanding of international clinical research standards and the ability to apply those standards to the researcher’s profession.

Applies Quality Standards to the Profession – Certified clinical researchers commit to the protection of human subjects, compliance with research regulations, and the quality of the data they collect.

Sets a Professional Apart from Others – Researchers who gain certification show their commitment to quality, ethics, and international research standards which sets them apart from those without certification. Clinical research certifications prepare researchers for career advancement and greater responsibility as leaders in their field.

Can increase Salary – Certified clinical researchers also have the potential to earn more than their non-certified colleagues.

Arizona State University

Johns hopkins university (aap), university of west florida, become a certified clinical research associate (ccra).

Certifying Agency: The Association of Clinical Research Professionals (ACRP)

Eligibility Requirements: Applicants must attest to having at least 3,000 hours of work experience performing the tasks and knowledge of the content areas of the CCRA exam. Experience older than ten years will not be considered. See below for exam content details.

Up to 1,500 hours of work experience may be substituted for one of the following options:

• Current ACRP-CP, CCRC, CCRA, and CPI Designation OR
• Graduate from a clinical research education program accredited by the Council on Higher Education Accreditation (CHEA)

All applicants undergo a formal eligibility review process upon application.

Exam Details: The exam assesses proficiency in six core knowledge areas including:

Candidates must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CCRA Exam Handbook from the CRA Certification page under “About the Exam”.

• Exam Format: 125 multiple-choice questions that test knowledge based on memory, application, and analysis of information
• Exam Duration: Maximum of three hours
• Exam Delivery: Secure computer terminals
• Exam Language: English
• Exam Fees: Total exam fees range from $435 to $600 depending on ACRP membership status and when applicants apply for the exam (early-bird or regular). This includes an application fee and an exam fee. Note that all non-members will receive one year of ACRP membership upon passing the exam.
• Exam Dates: Spring 2024 Exam Dates: February 15 to May 15, 2024; Fall 2024 Exam Dates: July 15 to October 15, 2024

Renewal Process: According to the Maintenance of Certification Program through ACRP, certified individuals must participate in 24 contact hours or points of continuing education and activities every two years. Alternatively, they may retake the certification exam.

Careers for CRAs: Clinical research associates are employed by sponsors from pharmaceutical companies, device companies, grant companies, universities, sponsoring physicians, or other entities. They serve in the role of an independent monitor in the administration and progression of clinical trials on behalf of the sponsor. CRA certification can advance a career as a:

• Clinical Research Associate
• Research Nurse
• Independent Consultant/Contractor

Become a Certified Clinical Research Coordinator (CCRC)

Eligibility Requirements: Applicants must attest to having at least 3,000 hours of work experience performing the tasks and knowledge of the content areas of the CCRC exam. Experience older than ten years will not be considered. See below for exam content details.

Examinees must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CCRC Exam Handbook from the CRC Certification page under “About the Exam”.

• Exam Fees: Total exam fees range from $435 to $600 depending on ACRP membership status as well as when applicants apply for the exam (early-bird or regular). This includes an application fee and an exam fee. Note that all non-members will receive one year of ACRP membership upon passing the exam.

Careers for CRCs: Clinical research coordinators are employed by clinical research organizations under the direction of a principal investigator, who practices research under GCP guidelines. CRP certification can advance a career as a:

• Clinical Research Coordinator

Become a Certified Principal Investigator (CPI)

All CPI candidates must also provide proof of employment as a principal investigator (PI) or sub-investigator (sub-I) on two clinical trials.

Up to 1,500 hours of work experience and one clinical study PI or sub-I position may be substituted for one of the following options:

Examinees must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CPI Exam Handbook from the PI Certification page under “About the Exam”.

Renewal Process: According to the Maintenance of Certification Program through ACRP, certified individuals may take the current certification exam or they must participate in 24 contact hours or points of continuing education and activities every two years.

Careers for CPIs: Principal Investigators hold a PhD or equivalent and are responsible for the ethical and safe conduct of clinical trials. CPI certification can advance a career as a Principal Investigator.

Become a Certified Clinical Research Professional (CCRP)

Certifying Agency: The Society of Clinical Research Associates (SOCRA)

Eligibility Requirements: Applicants must be working under Good Clinical Practice (GCP) guidelines and must meet one of the three following criteria sets:

• Two years of experience as a full-time clinical research professional or 3,500 hours of part-time experience during the last five years
• Associate, undergraduate, or graduate degree in clinical research and has a minimum of one year of full-time experience or 1,750 hours of part-time experience during the past two years as a clinical research professional
• Undergraduate or graduate certificate in clinical research with no less than 12 semester credit hours or totaling 144 credit hours from an academic institution of higher learning; an associate or bachelor’s degree in a pharmacy, science, health science, or related field; and a minimum of one year of full-time experience or 1,750 hours of part-time experience during the past two years as a clinical research professional

Applicants must submit an application, resume/CV, job description, verification of employment letter, and signed ethics statement.

Exam Details: The exam focuses on five content areas patterned after the 2017 SOCRA Job/Task Analysis. Examinees can download a detailed exam outline . Generally, candidates are tested on ethical principles, safety, informed consent; clinical trial protocol and amendments; institutional review board/ethics committee roles and responsibilities; investigator roles and responsibilities; and sponsor roles and responsibilities.

• Exam Format: 130 multiple-choice questions that assess understanding and application, 30 of which are beta testers and are not scored. Examinees must answer 72 of the 100 scored questions correctly to gain certification.
• Exam Duration: Maximum of four hours
• Exam Delivery: Paper and pencil format or computer-based testing
• Paper/Pencil (Members: $395, non-members: $450)
• Computer-Based Testing (Members: $395 + $115 within North America, +$175 outside North America, non-members: $450 + $115 within North America, +$175 outside North America)
• Exam Dates: Paper and pencil format dates run throughout the year in various locations. Computer-based testing is determined once the application is approved.

Renewal Process: Certification is valid for three years and must be renewed by application . CCRPs must complete 45 hours/credits of continuing education during this period, 22 of which must be related to clinical research. The other 23 hours may concern the professional’s specific career path. The fee to renew is $350.

Careers for CCRPs: Because clinical research professionals come from various professional paths, CRP certification can help advance careers in medical technology, nursing, statistics, biology, teaching, health records, administration, pharmacy, and other careers.

Become a Certified Research Administrator (CRA), Certified Pre-Award Research Administrator (CPRA), or Certified Financial Research Administrator (CFRA)

Certifying Agency: The Research Administrators Certification Council (RACC)

Eligibility Requirements: Candidates must comply with one of the following criteria sets:

• Holds a bachelor’s degree and has three years of experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization OR
• Holds an associate’s degree and has five years of experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization OR
• Has six years of professional experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization; candidates falling into this category must complete a petition application including two letters of reference

The third option is only available through a special petition process and each petition is evaluated on a case-by-case basis.

Exam Details: The questions for each type of exam are obtained from previously certified individuals in those fields (CRA, CPRA, and CFRA). Exam sections consist of varying topics depending on the certification and include some of the following: project development and administration, legal requirements, research partnership and funding, project costs, fiscal compliance, and more.

• Exam Format: CRA (200 multiple choice questions); CPRA (250 multiple choice questions); CFRA (200 multiple choice questions)
• Exam Delivery: Computer-based testing at certified PSI testing facilities
• Exam Fees: $395
• CRA: Spring – May 11 to May 25, 2024; Fall – November 2 to November 16, 2024
• CPRA: Spring – February 17 to March 2, 2024; Fall – August 17 to August 31, 2024
• CFRA: Spring – March 2 to March 16, 2024; Fall – September 7 to September 21, 2024

Tests are administered Monday through Saturday during the outlined two-week exam windows at various PSI locations throughout the U.S. and Canada.

Renewal Process: Certification is valid for five years. Renewal for another five years follows these requirements:

• CRA recertification requirements include 80 hours of continuing education, either taken or taught, or activities participated in, and three questions for use on a future certification exam. Educational activities include a variety of options as defined by RACC.
• CPRA recertification requirements include 80 hours of continuing education, 80 percent of which must be related to pre-award activities; or by retaking and successfully passing the CPRA exam.
• CFRA recertification requirements include 80 hours of continuing education, 80 percent of which must be related specifically to financial activities; or by retaking and successfully passing the CFRA exam.

Become a Certified Clinical Data Manager (CCDM)

Certifying Agency: The Society for Clinical Data Management (SCDM)

Eligibility Requirements: Applicants must meet one of the four following criteria sets:

• Holds a bachelor’s degree or higher and has a minimum of two years of full-time clinical data management experience
• Holds an associate’s degree and has a minimum of three years of full-time clinical data management experience
• Has four or more years of full-time clinical data management experience
• Has part-time work experience that equals or surpasses the full-time experience requirement

Applicants must submit an application as well as a CV.

Exam Details: The exam seeks to establish a universal standard of education, experience, and knowledge by which certified individuals would be recognized in the profession of clinical data management.

• Exam Format: 130 multiple-choice questions that assess competence and expertise in the field of clinical data management
• Exam Duration: Maximum of 3.5 hours
• Exam Delivery: Online, computer-based exams at testing centers
• Exam Fees: Exam fees range from $125 to $325 depending on membership and country of origin. There is a reduced fee for retaking the test within one year
• Exam Dates: Exams are scheduled through Prolydian and are proctored virtually, so there is no need to travel to a testing site.
• Renewal Process: Renewal fees range from $60 to $150 depending on membership and country of origin. Certification is valid for three years. CCDMs must obtain 18 continuing education units (CEUs) within three years, 60 percent of which must be directly related to clinical data management training.
• Career Enhancement for CCDMs: Clinical data management professionals can enhance their career through certification by validating a specific skill set and knowledge that certifies them as experts in their field and shows the ability to mentor and prepare others for certification as a CDM.

Certification can benefit organizations because by hiring CCDMs, the company ensures best practices, efficiency, improved quality, comprehensive knowledge, excellence in the field, and a commitment of employees to professional development.

Learn More About Clinical Research Certification

Clinical research professionals wishing to learn more about clinical research certification can take a free online course offered by The National Institutes of Health . Topics covered by the course include:

• Roles and responsibilities of the investigator and the institution
• Regulatory issues
• Ethical issues involved in human subjects research
• Clinical investigators and the mass media

This course is offered 24 hours a day online and offers an exam at the end. Attendees who gain a score of 75 percent or higher on the exam will receive a certificate that verifies that the participant has gained an overview of the information presented in the course.

With her passion for uncovering the latest innovations and trends, Kimmy Gustafson has provided valuable insights and has interviewed experts to provide readers with the latest information in the rapidly evolving field of medical technology since 2019. Kimmy has been a freelance writer for more than a decade, writing hundreds of articles on a wide variety of topics such as startups, nonprofits, healthcare, kiteboarding, the outdoors, and higher education. She is passionate about seeing the world and has traveled to over 27 countries. She holds a bachelor’s degree in journalism from the University of Oregon. When not working she can be found outdoors, parenting, kiteboarding, or cooking.

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Home » Blog » CCRP Certification: ACRP vs. SOCRA

CCRP Certification: ACRP vs. SOCRA

Table of Contents

The Value of Certification & Certifying Organizations

In addition to experience and career accomplishments, CCRP certification can provide added credentials for CRAs to progress further. It is common to see job advertisements that list certification as one of the preferred quality a candidate should possess. CCRP certification shows that a CRA is willing to go the extra step to pursue professional certification.

Below, I’ll talk about the 2 main clinical research organizations (ACRP and SOCRA) that are well recognized among those in the industry and the type of certifications that they offer.

The Association of Clinical Research Professionals (ACRP)

The Association of Clinical Research Professionals (ACRP) is one of the two clinical research professional organizations that are well recognized. ACRP is the older (established in 1976) and the larger of the two organizations, with more members worldwide.

ACRP offers membership, certifications, classes, conferences, career resources, and job postings. ACRP also offers an online forum and local chapter meeting around the world for networking opportunities and learning events.

For certification, ACRP offers a certification for clinical research coordinators (CRC), which is called Certified Clinical Research Coordinator (CCRC). I had a CCRC certification when I was working at a hospital site as a CRC. ACRP also offers a certification for clinical research associates (CRA), which is called Certified Clinical Research Associate (CCRA). Below are some steps for a CRA to become a certified CCRA through ACRP:

• Become an ACRP member ($150 annual membership fee in United States, $60 annual membership fee for emerging market – electronic membership)
• Register for CRA certification exam ($460 – $600 fee, must meet one of the eligibility options below and provide detailed CV/resume and job description.
• Take and pass the CCRA examination
• Renew CCRA your certification every 2 years ($215 – $325 renewal fee)
• Report twenty-four (24) contact hours / points every two (2) years -or-
• Take the current Certification Exam

The Society of Clinical Research Associates (SOCRA)

The Society of Clinical Research Associates (SOCRA) is the newer of the two clinical research professional organizations. It was established in 1991. Similar to ACRP, SOCRA is well recognized among those in the industry. SOCRA offers membership, certifications, classes, conferences, career resources, and job posting. SOCRA does not offer an online forum, but SOCRA does have local chapter meetings around the world for networking opportunities and learning events.

As for certification, SOCRA is different than ACRP in its approach. Instead of offering separate certification for Clinical Research Coordinators (CRC) and Clinical Research Associates (CRA), SOCRA offers one certification for both. This is called the Certified Clinical Research Professional CCRP certification. I got my CCRP certification through SOCRA. Below are some steps for a CRA to become a certified CCRP through SOCRA:

• Become a SOCRA member ($75 annual membership fee)
• Register for the CCRP certification exam ($395 fee, must meet one of the eligibility options below and provide detailed CV/resume, verification of employment, and job description. Click here for more details.
• Take and pass the CCRP certification exam
• Renew your CCRP certification every 3 years (maintain membership during the 3 year period, $75 fee per year plus a $100 processing fee)
• Report 45 continuing education hours every three (3) years AND
• Take the recertification knowledge quiz (open-book quiz)

ACRP vs. SOCRA CCRP Certification

Both ACRP and SOCRA are well recognized among those in the industry. The decision to choose between ACRP and SOCRA for a CRA may come down to the consideration below:

Which organization do you want to be a member of?

• ACRP is older and has more members
• ACRP is has an online forum

Which eligibility requirements do you meet?

• SOCRA’s CCRP certification is available to anyone who has worked full time in the field of clinical research for at least 2 years as a Clinical Research Professional.
• ACRP’s CCRA certification is available to only those meeting specific CRA/monitoring job functions

How much studying are you willing to put into to passing the exam?

• SOCRA’s CCRP certification exam is easier (unofficial opinion from my own experience and from what I heard from friends and colleagues over the years).

How often do you need to renew the certification and the number of continuing education credit needed?

• ACRP requires 24 credits every 2 years (12 credits/year)
• SOCRA requires 45 credits every 3 years (15 credits/year)

How much does it cost for membership and maintaining your certification?

Below are some estimates of total cost (assuming membership is maintained during renewal period)

Full Comparison Table

Why i chose socra ccrp certification.

I had ACRP’s CCRC certification when I was a CRC in 2010. I chose not to renew the CCRC certification after becoming a CRA soon after. I have been SOCRA CCRP certified since September 2013. The reason I chose SOCRA’s CCRP certification was due to the lower cost and the longer period of renewal.

For those considering SOCRA’s CCRP certification, I have a study guide that helped me pass the exam with 96% out of 100% grade ( click here to see my score). This study guide contains the notes that I compiled for my own study.

Even though materials on the notes are from publicly available sources (ICH GCP, FDA’s CFR, resources from internet, etc.), I find the vast amount of information to be overwhelming, especially with limited study time in between my daily workload.

This study guide includes summaries of information in an easy-to-read format, as well as my own knowledge and experience in clinical research. I bring both clinical research coordinator (CRC) and clinical research associate (CRA) perspectives, as I had worked in both roles in my career. Visit the homepage to learn more!

Ernie Sakchalathorn

Great info. Appreciated

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• Exam Overview

SOCRA established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community. Those individuals so approved may use the title "Certified Clinical Research Professional" or "CCRP® (SOCRA)"

Background Information

Clinical research professionals come from a wide variety of backgrounds with even more varied job descriptions. Some clinical research professionals are MDs, while other are RNs; some may have a degree in medical technology, business administration, health information management, statistics, biology, teaching, or other areas. Every one of these backgrounds brings special areas of expertise to the field of clinical research. Each institution and discipline has unique requirements.

Despite the varied backgrounds and job descriptions, all clinical research professionals are guided by a common framework of regulations, guidelines and ethical principles in the conduct of clinical research. Therefore, the examination is designed to assess the applicant’s ability to apply the U.S. Code of Federal Regulations, ICH Guidelines, and ethical principles that guide the conduct of clinical research under the scope of GCP, highlighted in the standards of practice.

Examination Development

The Certification Examination has been developed by the SOCRA Certification Committee and SOCRA Certified Clinical Research Professionals (CCRPs®) who have demonstrated expertise in the development, management, and administration of clinical trials. These clinical research subject-matter experts (SMEs) come from diverse backgrounds and job descriptions to reflect the composition of SOCRA membership.

The test questions are designed to be straightforward and easily understood. The questions are reviewed by experts in test question development and SOCRA language representatives for fairness and readability.

The Certification Examination is evaluated and updated at least annually in order to assure that it is up-to-date and reflective of the current regulatory environment in which clinical trials are performed.

The certification exam content areas have been reviewed and validated through completion of a Job/Task Analysis. A copy of the Job / Task Analysis summary is available by request through the SOCRA administrative office.

Examination Validation

The exam is statistically and psychometrically validated by independent consultants. The Certification Committee evaluates the results from statistical/psychometric evaluations and updates the exam as needed.

The examination pass/fail score, or “cut score”, is statistically determined by a panel of experts using the "Modified Angoff Method." The “cut score” is validated after a review of the psychometric testing analysis.

Certification

• Program Overview
• CCRP Certification Quick Facts
• Definition of a Clinical Research Professional
• Certification Program Policies
• Removal of CCRP® Credential
• Verify Certification
• Candidate Eligibility
• Application and Fee
• Computer Based Testing Exams
• Paper and Pencil Exams
• Refunds, Rescheduling and Retesting
• SOCRA Sponsored Exam Schedule
• Exam Outline
• Preparing for the Exam
• Preparation Resources
• Examination Results
• Host an Exam at Your Site
• Apply Online
• Exam Schedule SOCRA Sponsored Sites
• Requirements for Maintaining Certification
• Continuing Education Requirements
• Descriptions of Acceptable CE
• CE Recordkeeping Requirements
• Request for SOCRA CE for Courses / Workshops
• Installment Plan Payment
• Renewal of Certification
• Recertification Audit
• Recertification Learning Module
• Accreditation

2024 ANNUAL CONFERENCE

ADVANCING INNOVATION AND INTEGRITY:

A TIME FOR TRANSFORMATION IN CLINICAL RESEARCH

8 tracks I 20+ Topic Areas I 100+ Sessions I 70+CE

Clinical Research Associate

Clinical Research Associate Certification

Demo Clinical Research Associate Certification

CRA Training

CCRPS CRA Graduates obtained many job roles including:

Clinical Research Associate, Clinical Trial Monitor II, Research Associate, CRA II, Scientist, Quality Assurance Analyst, Senior Clinical Research Associate, Research Associate in Discovery Immunology, Clinical Trial Monitor/CRA, Clinical Trials Project Manager, Associate Director of Research Nursing, Clinical Trial Navigator, Clinical Director for R&D, Senior Clinical Research Associate, Clinical Research Professional, Medical Science Liaison, Clinical Trial Associate III, Quality Assurance Associate II, IRB/SRC Analyst II, Project Manager, Clinical Trial Associate, Clinical Research Coordinator, Public Health Advisor, Associate Scientist II, Strategy Analyst, Clinical Research Associate II, Clinical Operations Specialist, Advisor - Development Clinical Research Scientist, Neuroscience, Associate Clinical Engineer, Clinical Trial Management Associate, Quality Supervisor, Clinical Research Data Coordinator (2024 CCRPS Graduate LinkedIn Survey).

Clinical Research Associate Training

Advanced clinical research associate certification (acrac), introduction.

CME Handout

Common Terminology Used In Clinical Research - Reference Glossary

Commonly Used Abbreviations and Terms in Clinical Research

Roles and Relationships in Clinical Trials

Duties and Responsibilities of a Clinical Research Associate (CRA, Monitor)

Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

Communication between Blinded and Unblinded Staff

Contract Research Organizations (Delegation, Responsibilities, Management )

Sponsor and Investigator Roles

ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators

ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

Clinical Trial Design

Advanced Designs of Clinical Trials

Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

Blinding and Unblinding in Clinical Trials

ICH GCP - Overview

An Introduction to Clinical Research

An Overview of ICH GCP

ICH GCP - Ethical Research in Vulnerable Populations

Ethics of Research Involving Children

Ethics of Research Involving Mentally Incapacitated

Ethics of Research Involving Prisoners

Ethics of Research Involving Pregnant Women and Fetuses

Adverse Events

Advanced Review of Adverse Events

Clinical Trial Protocol

The Clinical Trial Protocol - Advanced Mastery Review

Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

Protocol Deviations and Violations

Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

IRB and DSMB

Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

Data Safety Monitoring board- DSMB

Review Questions

REVIEW: Review Questions for ICH GCP (for study purposes, not graded)

Site Monitoring Visits

Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

Site Qualification Visit (SQV)

Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

Site Initiation Visit (SIV)

Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"

Routine Monitoring Visit (RMV)

Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)

Site Close-Out Visit (SCOV)

Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)

Tools for Monitoring Visits

Monitoring Tools and Softskills (Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities)

Develop Templates for Monitoring Visits (Site Preparation, Pre-visit Letter/Agenda, Visit Checklist, Followup Letter, Visit Report)

Audit and Inspections

Audits and Inspections in Clinical Trials

FDA Bioresearch Monitoring Program (BIMO)

FDA Warning Letter

Audits and Inspection Review Questions (for study purposes, not graded)

REVIEW A: Quality Monitoring Review Questions (for study purposes, not graded)

SDV and Informed Consent

ICH GCP Section 4.8 Informed Consent

Source Documents and Informed Consent Forms (SDV Checklist, Informed Consent Checklist)

Minimizing Source Data Queries In Clinical Trials

Case Report Form

Guidelines for Designing and Completing Case Report Forms

Do’s and Don’ts of a Case Report Form Design

Quality Control and Safety

Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)

ICH GCP - Safety of Human Subjects in Clinical Research

Technology in Trials (IVRS, CTMS, EDC)

ICH GCP - Trial Management, Data Handling, and Record Keeping

Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)

Clinical Trial Management System-CTMS

Electronic Data Capture and Remote Data Capture Basics

Electronic Regulatory Submission and Review

Modernized Monitoring (Remote, Risk-based, Centralized)

An Overview of Remote Monitoring - COVID-19 Update

Remote Monitoring of Clinical Trials and EMRs

Centralized Monitoring

Pharmacovigilance and Regulatory Affairs

Advanced Practice of Pharmacovigilance

Regulatory Affairs for Clinical Trials

Investigational Product

Investigational Product Storage and Dispensing

Investigational Product Accountability in Clinical Trials

Local and Central Labs

Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)

REVIEW PART B: Quality Monitoring Review Questions (for study purposes, not graded)

Regulatory Documents

Regulatory Documents in Clinical Trials

Delegation of Authority Log – DOAL

Investigators Brochure (IB)

CFR 21 Part 11 - Electronic Signatures

Code of Federal Regulations

CFR 21 Part 11

New Drug Application

The Investigational New Drug (IND) & New Drug Application (NDA) Process

Investigator Initiated Multi-Center Trials

IND and IDE AE Reporting

Safety Reporting Requirements for Sponsor Investigators of An IND

Trial Master File

Essential Regulatory Documents Binder Tab Organization (Trial Master File)

Trial Master File Reference Guide

Regulatory Training Quiz

Disclosures and Payments for PI, Site, Patients

Financial Disclosure- Duties and Strategies for Clinical Studies

Payments and Budgeting for Investigators and Site

Advertisement Aid in Subject Recruitment and Retention

Patient Recruitment, Retention, and Compliance

Patient Recruitment in Clinical Trials

Patient Engagement and Retention in Clinical Trials

Patient Adherence and Compliance in Clinical Trials

Misconduct and Fraud

Scientific Misconduct and Fraud

Detecting Falsification

REVIEW PART C: Quality Monitoring Review Questions (for study purposes, not graded)

Site Visit Templates

SQV Checklist

SQV Questionnaire

SQV Assessment

SQV Follow Up Letter

SIV Confirmation Letter

RMV Confirmation Letter/Fax

RMV Follow Up Letter

CRA TRANSITION Letter/Email/Fax

SCOV Confirmation Letter

SCOV Agenda

SCOV Report

SCOV Follow Up Letter

REFERENCE Module

Final Examination

Competency Exam

Start Today

• Monitor Trial Sites
• Preferred 4 Year Science Degree or RN License or Prior CRC
• Salary $60-120k+. High promotion rate.

View CCRPS Clinical Research Associate Graduate Case Studies April 2024

Enjoyed Clinical Research Training through Examples  “The real-world examples used throughout the course were incredibly useful for applying theory to practice.”  -Marta Marszalek  ( view full case study )

Case Summary:  Marta Marszalek completed the  CRA certification course seeking to deepen her theoretical knowledge and practical skills in clinical research to complement her monitoring activities and comply with industry standards.  Marta appreciated the self-assessment opportunities, which helped identify areas that needed review. Adding the certification to her CV and LinkedIn profile significantly increased her marketability and helped secure new job opportunities,  affirming the practical benefits of the course. 

From International CRC to U.S. Lead CRC and CRA:   “The flexible online format allowed me to balance my studies with my professional commitments seamlessly.” -  Aishwarya Sukumar  ( view full case study )

Case Summary:   Aishwarya Sukumar completed the CCRPS CRA certification course to enhance her understanding of FDA regulations and adapt to the clinical trials industry in the United States after relocating from abroad.   Chose the CCRPS program for its  affordability and flexibility , crucial as she was adjusting to new motherhood and transitioning careers in a new country . Successfully transitioned from a CRC to a Lead CRC, and then to a CRA role , underscoring the significant career advancement facilitated by the course.  The course facilitated a  smooth transition into the clinical research field in the U.S. , providing her with necessary certifications and boosting her credibility in job interviews.

  From IMG to securing roles as a CRC, CRA, and now a project manager:  “Joining this course was a pivotal step in my career advancement.”  - Dr. Vrushali Borawak  ( view full case study )

Case Summary:   Dr. Borawake successfully transitioned from medicine in India to clinical research in Germany, attributing significant career advancements to the CCRPS CRA training.  She secured positions as a Clinical Research Associate (CRA), and has recently advanced to a Project Manager role.  The courses  provided her with essential knowledge and confidence, particularly in job interviews , by familiarizing her with industry-specific terminology and documentation. Dr. Borawake highlighted the c ourse's effectiveness for international medical professionals  seeking to enter the clinical research field in Germany or other countries, noting its comprehensive coverage of relevant regulations and practical applications .

From Masters in Health Safety to Clinical Research Associate:   " I will say quality of delivery, quality of the materials.   - Ossai Opene  ( view full case study )

Case Summary:  Ossai appreciated the straightforward,  easy-to-follow video presentations  and found the sample questions at the end of each module particularly useful for reinforcing learning.  He found the roles and connections between CROs and CPIs most engaging and informative, providing  clear insights into the clinical research operation landscape . Ossai would recommend the course based on the quality of materials, self-paced format, and positive testimonials  from other learners. The course equipped Ossai with the necessary skills and knowledge to transition into clinical research, enhancing his understanding of industry standards and practices.

From Grant Program Manager to Leading Clinical Trials at UCSF :  "it really did a great job of the full scope of clinical research from start to finish. Since completing the course, I've received a promotion at work. "  -Hannah Fischer  (view HF clinical research training case study)

Case Summary:   Before CCRPS, Hannah Fischer Was A Grant Manager having difficulties with Clinical Trial Coordination . After CCRPS She Elevated to Clinical Trial Leader at UCSF, Excelling in Trial Management and Grant Applications. T he certification and the knowledge gained from  the course played a crucial role in Hannah securing a promotion at work , illustrating the career enhancement potential of the program. The content was comprehensive and directly applicable to her current role in managing clinical trials, significantly aiding her daily responsibilities and strategic approach.  Hannah  actively recommended the CCRPS program to her colleagues, emphasizing its thorough approach to explaining the clinical trial process from start to finish.  Her endorsements highlight the program’s applicability and value across her professional network.

Enroll Schedule Advising

CCRPS Reviews

Cra certification, detailed information, oladipo owoyomi.

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, hi...

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, highly inspiring. I recommend it for anyone with a research drive.

Lifechanging for my career

Latoya munroe.

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experienc...

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experience as I was introduced to Clinical Research Associate Certification. Hoping to build a career through this. Awesome experience

Amazing all inclusive course

David narouz.

The test was ever hard, I have studied and passed the CRA in 1 month of intensive study and would encourage anyone to take it.

Extremely well presented CRA course!

Abiodun babayeju.

This course is detailed, well presented, and provides all you need to become a confident CRA!

Fantastic tool to expand my CV

Marquise jeffery, kenny adazie, my thoughts, tondor cleopatra uzosike.

A very educative Course. Highly recommended

It is an excellent presentation with good speed in clear...

Cynthia zhao, patient recruiting and retaining, lynda agboola.

not too long but precise

Phd In Monitoring

Adriana paz mancia.

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to ...

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to life through discovery and application. So many topics are covered almost like a bootcamp for phd in trials.This is helpful

Subhash Soni

Good to understand, temitope oshineye, accelerated, zehra abbas.

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with histo...

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with history background and by other as well with thehelo of the slides.

a fundamental stepping stone for all monitors

George grudziak.

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn ...

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn what is covered in just a chapter. I refer back to the course every time I switch to a new trial to refresh my knowledge.

Mary Dahodu

Great course with high knowledge impaction. Platform also was easy to navigate.

Dedication to real material

Asra feroze.

The diligence and direction provided by this course material has inspired my inner confidence to climb high to reach the pinnacle of my ambitions.

Refreshed my knowledge after 10 years in monitoring

Dr. sharib syed muhammad.

Best refresher for clinical researchers. A lot of content but can skim modules if you know them well.

CCRPS trains monitors to succeed in remote and local site...

Esohe ayanru.

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to m...

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to move up. This course was so advanced and really made sure you understood all the core guidelines and monitoring report processes. It made me feel much more comfortable when applying for new jobs.

two weeks to update your resume

Shivani dhotre.

CRA training took me about 2 weeks straight. I learned a lot and videos were very refreshing. It was noticed by recruiters on resume.

A great review of clinical research for monitors

Jayant shrivastava.

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lo...

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lots of templates in each module for SIV and other things which I really liked.

Learn by examples. Great follow through videos.

Abiodun adegbite.

Exceptional information not found anywhere else. Everything has an example. Content just makes sense as dry as reviewing protocols and guidelines can be.

Remarkabley accurate lectures that go into so many reason...

Vaishnav nath ajeendra nath.

This course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quit...

This course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quite a lot of foundation and practical skills. This was an absolute wonderful learning experience on this platform, thanks for the assistance and hope to continue to learn from this experience, thank you...

ACRA Training

Ossai a opene.

Great class and easy to follow. The materials are sequential and great review questions. I strongly recommend the training to any one that wants to get int...

Great class and easy to follow. The materials are sequential and great review questions. I strongly recommend the training to any one that wants to get into the CRA space.

Gertrude Nenanya

Detailed and Informative. A lot to take in yet rich with step-by-step information to prepare anyone new to clinical research

clinical research associate

Khalel imanbayev, sathya ramamoorthy, best way to start a new career as an img.

I decided to switch careers shortly after finishing my bachelors and was recommended to look into clinical trials. This program was essential in my career ch...

I decided to switch careers shortly after finishing my bachelors and was recommended to look into clinical trials. This program was essential in my career change and honestly everything made sense so I felt like I really understand and enjoyed the material! You don’t need a science background to take this.

Knowledgeable

Norah okafor.

It has really been of great impact with my 5 years experience as a CRC.

Very good content

Great course for updating information and knowledge

Mohammad ismail, dr. jennifer campbell-allman, dr. jennifer campbell-allman, phd. msc., rmhci., very detailed information, goliath sakala.

This course is very detailed and informative.

Only resource CRAs need

Husnain arshad.

Very interesting and useful for CRA training

Advance Clinical Research Associate

Charity oparah, acrac review, cyprian suh.

Very, very enriching; content and presentation.

It is informative

Safeyeh alghazali, adeyinka balogun agesin, its a great opportunity for me to review again all aspect..., adam friday.

EXCELLENT EXPERIENCE

Loving my training!

Corinthia mims.

I really appreciate the ability to return to a section to observe again. I like being able to take my time to learn.

Sergiy Ivashchenko

Very Good Course

CRA Training Program

CRAs monitor clinical trial sites for compliance with guidelines and protocols. Salary of $60k to 120k+ based on experience level.

Requirement

A minimum of 4 year degree in science required though scientists, IMGs, nurses, prior coordinators, and even senior CRAs take our course.

Takes 2-4 weeks. Start today. Self-paced. 3k+ enrollees choose us because of our advanced curriculum with practice applications and competitive pricing.

Certification

Triple-accredited course with 17.5 CME. Achieve 70% on 2 attempts on MCQ exam.

How to become a clinical research associate

To become a clinical research associate, you must first complete an accredited clinical research associate training program. The course provides an extensive review of the regulations and principles of clinical research, as well as practical application of the skills needed to execute and manage trials correctly.

Clinical research associate certification test covers topics like clinical research protocols, FDA regulations, Good Clinical Practice (GCP), ICH guidelines, data management and more. If you pass the exam, it means you're certified as a CRA.

You can get clinical research associate training online free with webinars, tutorials, eBooks and other materials related to the profession. This can help you learn more about the job before you get certified.

What is a clinical research associate

A CRA makes sure clinical trials are done correctly and on time. They make sure the clinical trial follows the plan, good clinical practice guidelines, ethics, and laws. CRA's must know a lot about trial protocols, patient safety, data integrity and regulatory requirements to guarantee the quality of a clinical trial.

Clinical Trial Associate

A clinical research monitor will review study sites' data collection processes to ensure that all data collected is complete and accurate. This includes conducting on-site visits to assess study sites' compliance with good clinical practices (GCP), review case report forms (CRF), and periodically audit research sites to ensure compliance.

Clinical Trial Monitoring

Clinical research associates do things like teach the protocol; talk to human subjects and their families; get ready for investigator meetings, trainings, documentations; manage study supplies inventory; track subject enrollment, visits, data reports, study timelines; and solve any problems that come up during the study.

Why get clinical research associate training

Clinical trial monitoring job growth.

Getting certified as a Clinical Research Associate (CRA) gives you the opportunity to start earning salaries of up to $100,000 and 33% of new CRAs receive promotions within the first year.

Clinical research association accreditation

The ACRAC training program is internationally accredited by industry standards including IAOCR, ACCRE, AMA, ACPE, ANCC to provide comprehensive training for those holding at least a BA in Science.

Fast track clinical research training

Flexible online training and on-demand video modules that can be completed in as little as 2 weeks for a clinical research associate fast track career.

Clinical Research Associate Salary

Salary for clinical research associate

Clinical research associate salary (CRA) is typically higher than the national average and varies depending on experience, job title, city of employment and industry. The average annual salary for a CRA was estimated to be $80,000 in 2024.

Entry-level clinical research associate salaries can range from $47,000 - $80,000 per year. As a CRA gains more experience and furthers their education, they may be able to negotiate higher salaries due to their valuable knowledge and skills.

can exceed $90,000 in certain geographies or with specialized skillsets. Generally speaking, the higher the level of education or specific certifications held by a CRA, the higher salary they can expect to earn.

Various factors impact how much a CRA can earn such as their employer’s size and industry sector (pharmaceuticals vs biotechnology companies), amount of travel required for research responsibilities and tasks assigned.

Clinical research associate job description

What does a clinical research associate do

Developing Protocols and Case Report Forms

The Clinical Research Associate is responsible for creating clinical research protocols and Case Report Forms. This includes writing instructions, outlining procedures, collecting data, assessing collected samples/specimens, and making sure people follow the protocol/investigational plan.

Monitoring Clinical Study Sites and Teams

The CRA role includes making sure that sites are monitored, data is accurate, and reviewing source documents. They also manage a team of physicians, nurses, support staff (if applicable), vendors (such as laboratories) involved in the clinical trial and providing training on protocol requirements in order to achieve successful outcomes from each trial/study conducted.

Ensuring Regulatory Compliance

CRAs need to make sure they follow all the rules and regulations for conducting studies. This includes making sure the studies are safe for patients, ethical, and accurate. CRAs also need to attend regular meetings with people who are involved with the study to discuss any changes in the rules or regulations that could affect how the study is conducted.

Clinical Research Associate Jobs

How to obtain a CRA job

Utilize online job boards, such as Indeed and Glassdoor, to search for open positions. When searching, use keywords such as "clinical research associate jobs", "clinical research associate job", "clinical research associate jobs entry level" and "remote clinical research associate jobs". Make sure to write a cover letter.

To find potential employers as a Clinical Research Associate, look in directories of medical companies or local businesses.Contact the employer by email or phone and tell them why you would be good for the job they are trying to fill.

Talk to people who have jobs like the one you want, follow professional organizations on LinkedIn, and go to events where you can meet these people. This way, you might hear about job openings.

Check social media for job postings by following accounts related to Clinical Research Associates and checking them regularly for new postings that might be a good fit for you.

Clinical Research Associate Certification FAQs

Clinical research associates (CRAs) are professionals who work in the pharmaceutical and healthcare industries to manage clinical trials and collect evidence. The primary role of a CRA is to ensure that all clinical trials and research studies are conducted according to legal requirements, ethical standards, and good clinical practices. CRAs interact with other healthcare professionals, researchers, patients, and sponsors to coordinate activities related to the trial. A successful CRA must have a strong background in science and medicine, as well as solid communication skills. Candidates for CRA jobs typically undergo training on Good Clinical Practices (GCP) prior to beginning their job duties. Clinical research associate roles include but are not limited to recruiting subjects for studies; designing protocols; performing administrative tasks such as budgeting; coordinating data collection; providing feedback on documents; conducting site visits; monitoring safety reports; reviewing patient records; preparing reports; analyzing data from clinical trials; maintaining records of trial progress; managing study databases; and developing clinical trial databases.

1) Spearhead the planning, implementation and evaluation of clinical studies by preparing study protocols, developing case report forms and managing data collection. This includes creating regulatory documents such as informed consent forms, patient diaries and Investigator's Brochures. 2) Monitor study progress with sites to ensure compliance with protocol requirements and regulations, such as Good Clinical Practice (GCP). Review raw data, verify accuracy and completeness of case report forms, analyze data using statistical software packages and participate in final report preparation. 3) Participate in the selection of sites for trials while maintaining professional working relationships with investigators. Generate metrics from study results and attend investigator meetings to provide target product profiles/project plans that align with organizational objectives.

1) Prepare study documents such as protocols, informed consent forms, case report forms and investigator brochures 2) Monitor sites to ensure compliance with study objectives, protocol requirements, good clinical practices (GCPs) and applicable governmental regulations 3) Ensure the accuracy of subject enrollment, data collection and handling processes 4) Oversee the maintenance of accurate source documents and regulatory binders 5) Manage investigator payments according to contract terms 6) Train site personnel on protocol and GCPs requirements 7) Track necessary regulatory documents such as licensure/DEA/IRB approvals; resolve any related issues with IRBs or other regulatory agencies. 8) Lead study start up activities including sending out essential materials to sites, distributing and completing required training for staff members; verifying that site initiation visits are completed timely 9) Prepare monitoring plans in consultation with the sponsor or CRO leadership; perform pre-study, initiation, interim and closeout visits at investigative sites as per study timelines. 10) Perform remote monitoring activities by regularly reviewing case report forms (CRFs), checking query log resolution status from sites. 11) Provide guidance on data entry queries from clinical research coordinators (CRCs) or other site personnel. 12) Monitor safety events reported by sites; notify appropriate parties promptly regarding serious safety events or protocol deviations. 13) Ensure that all adverse event reports are followed up for completion by review of medical records. 14) Generate routine visit reports using standard CRF formats; track budgets for each site according to protocol specific requirements & perform final reconciliation of monies within sponsor's payment system.

1) In order to become a Certified Clinical Research Associate (CRA) with CCRPS CRA certification, the first step is to research and obtain an undergraduate degree in any field related to clinical research, such as public health, healthcare administration or epidemiology. 2) Prospective CRAs should strive to gain experience in a clinical research setting through volunteer positions or internships within hospitals, clinics, universities or pharmaceutical companies. 3) The next step is to take and successfully pass the Certified Clinical Research Associate (CRA) exam offered through the Certified Clinical Research Professional Society (CCRPS). This comprehensive examination covers topics such as Good Clinical Practice (GCP), study design and implementation, regulatory compliance and ethics.

•CCRAs have a more standardized set of skills, which can help with advancing their career and obtaining higher salaries. • Becoming a CCRA provides greater opportunities for job advancement and the potential to improve salary. • Additionally, CCRA certification is a great way to demonstrate expertise, stay on top of industry developments, network within the field, and have access to exclusive resources.

1) Become an expert in clinical research studies. Take the time to learn as much as possible about different types of trials, protocols and procedures, as well as the regulations governing clinical research. Additionally, take advantage of any available continuing education opportunities and seminars to stay up-to-date on the latest developments in the field. 2) Develop strong organizational skills to effectively manage multiple studies, sites and deadlines. Create a system for tracking tasks and deliverables so that nothing falls through the cracks – this will keep sites, sponsors and investigators happy and maintain your reputation for excellence. 3) Establish yourself as a reliable source for knowledge both inside and outside your organization. Keep abreast of current trends in the industry so you can offer advice to others or answer their questions promptly; gain recognition by authoring publications or presenting at industry events; and always make sure your work is accurate and follows all applicable regulations.

1. PRA Health Sciences: A global biopharmaceutical organization that provides contract research services and drug development solutions to pharmaceutical, biotechnology, and medical device companies. 2. Syneos Health: A clinical services organization delivering integrated, tailored solutions to help customers accelerate the delivery of therapies to market with confidence. 3. IQVIA: A leading provider of integrated information and technology solutions for healthcare and life sciences organizations, helping them drive efficiency and effectiveness across all aspects of their business. 4. ICON Clinical Research: Providing strategic development advice and clinical trial execution services from a network of highly qualified site personnel across 63 countries. 5. Covance: A contract research organization (CRO) providing drug development solutions from laboratory testing services through to large-scale clinical trials in more than 25 countries worldwide 6. Chiltern International Ltd.: An award-winning CRO that offers full-service clinical development capabilities such as legal compliance support, project management, medical writing, data management/statistical analysis, safety/pharmacovigilance monitoring and global regulatory submissions assistance for clients in the US, Europe, Asia Pacific, South Africa and Latin America. 7. BioClinica Clinical Trials Solutions: Offering comprehensive eClinical suite that helps streamline processes related to study design, document management & reporting as well as imaging & safety data collection & review process management in real time around the globe for all types of studies—Sponsor-initiated Protocols (SIPs) or Investigator Initiated Studies (IIS). 8. Worldwide Clinical Trials: An award-winning CRO providing comprehensive clinical trial operations & data management services from initial concept development through final report generation across multiple therapeutic areas including oncology & rare diseases for both early phase studies & late phase trials in over 28 countries around the globe. 9. Clinipace Worldwide Clinical Trials Services: Specializing in creating innovative technology platforms for clinical research by combining its expertise in digital media with its deep understanding of regulatory policies thereby helping reduce complexities associated with managing large scale global projects involving multiple stakeholders from different parts of the world from start to finish – protocol design & buildout; patient enrollment & retention; site training; EDC builds; study closeout activities etc., involving both electronic data capture (EDC) based studies as well as non EDC based studies which can be delivered simultaneously or independently depending upon customer's requirements/goals at any one given point in time during the life cycle of a clinical trial project globally - US/EU/ROW markets etc., while adhering to the highest standards of quality assurance (QA), timelines and budget requirements resulting into improved operational efficiencies on part of our customers leading to better ROI figures towards end results achieved by successful completion of projects within stipulated timelines without compromising on Quality whatsoever!

1. Clinical research associates typically make an average of $53,000 a year, with a range between $45,000 to $62,000 annually. 2. The top 10 percent of clinical research associates can expect to make around $70,000 or more annually. 3. The lowest 10 percent of clinical research associates earn around $40,000 or less per year. 4. Mid-level salaries for clinical research associates usually fall within the range of $50,000 to $60,000 annually. 5. Incentives such as bonuses and commissions can significantly increase overall earnings for experienced clinical research associates. 6. Geographical location is often a factor in determining salaries for this profession; locations that tend to pay more include states like New Jersey, California and Massachusetts as well as metropolitan areas such as Seattle and San Francisco. 7. Other factors that may influence how much a clinical research associate earns include experience level and sector of the industry they are employed in (i.e., government, private or academic). 8. A career in this field offers many opportunities for growth and financial advancement; with additional education or certifications an individual could potentially make upwards of six figures annually after several years of experience in the profession.

Clinical Research Associate Course Syllabus

The CCRPS CRA program contents meets AMA requirements for 17.5 CME. This means that the course can help you succeed in your medical career. Additionally, the introductory chapter introduces you to clinical terminology and abbreviations commonly encountered in clinical research.

As a clinical research associate (CRA), it is important to know how to interact with other stakeholders in order to set up and monitor clinical trials for an investigational product or IP. These stakeholders include the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC), other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

The ICH-GCP guidelines provide procedures and precautions for protecting human research participants during clinical research. These guidelines cover obtaining informed consent from human subjects, maintaining trial records, reporting compliance and progress, as well as procedures for suspending or terminating trials. The chapter also covers the importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

This chapter will teach you about the different phases of clinical trials, from the pre-clinical phase to Phases 0-4. You will learn about important concepts like the structure and goals of each phase, dosing approaches, toxicology testing, and more. The chapter will also review the FDA's drug approval process.

The chapter provides an overview of GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

In chapter 6, we will learn about ethical research involving vulnerable populations. This includes people who are pregnant, children, mentally incapacitated individuals, and prisoners. We will learn about the challenges of conducting research with these groups of people, including obtaining consent from parents or guardians, providing fair incentives, and using deception or incomplete disclosure in a justified way.

This chapter covers the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects.

Chapter 8 is all about clinical trial protocols (CTPs). This chapter goes into detail about what a CTP is and how to write one. It also covers important concepts like study risk benefit analysis (RBA), sample size and statistical power, data analysis, risk management, and study administration. Additionally, the chapter addresses concepts related to choosing participants for the study, including inclusion and exclusion criteria, safety concerns, and ethical considerations.

This chapter will teach you about protocol deviations and violations. You will learn about the different types of deviations and violations, and how to distinguish between them. You will also learn about the most common violations, including minor ones (like off-schedule subject assessments) and major ones (like failure to report AEs). Finally, the chapter will review principles for reporting protocol deviations and IRB approval for planned deviations.

The IRB (Institutional Review Board) and DSMB (Data Safety Monitoring Board) are responsible for reviewing and approving research studies involving human subjects. This chapter reviews the history of these boards, and discusses the principles that guide their decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.

This module provides an overview of different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

This chapter provides a thorough understanding of the stages and steps involved in selecting a study site. The module reviews elements such as the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). It is important to learn about the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.

This module goes into detail about site initiation visits (SIVs). You will learn how to prepare for an SIV, including what approvals, permits, and licenses you need. Additionally, the module covers what should be on the SIV agenda, such as orientation and training for site staff. Finally, you will learn about post-SIV procedures, such as filing compliance documents like FDA form 1572 and Financial Disclosure Form (FDF).

This unit will teach you about routine or periodic monitoring visits. You will learn about the agenda of an RMV, which includes receiving updates on AEs from site staff and overseeing the progress of trials. The unit covers different approaches to site monitoring, including traditional (full-scale) monitoring and risk-based monitoring (RBM). It also compares on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is essential for obtaining accurate data from clinical trials.

This chapter covers everything you need to know about ending or finishing a trial site. This includes things like notifying the IRB and coordinating schedules among site staff (PI, other investigators, medical staff) and the monitoring team (CRC, CRAs, etc.), as well as preparing for an SCOV meeting – drug inventory management, database verification and lockdown, subject notification and completion of all subject-related documents, staff-related documentation, and other administrative tasks like compiling a close-out report.

This unit provides tips and tools to help a CRA (clinical research associate) effectively monitor clinical trials. The chapter lists physical accessories that can be useful for monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions.

This module will help you understand and prepare for audits and inspections by the CRO, FDA, or other regulatory authority. It covers the difference between an audit and an inspection, and provides detailed protocols for both. Additionally, it outlines the sequence of an FDA inspection, including a walk-through of the Biomedical Research Monitoring Program inspection. You will learn about important audit and inspection documents, such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation). You will also learn about the Establishment Inspection Report (EIR) prepared by the auditor/inspector. Finally, you will understand the different types of observations in an EIR, including NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated).

This chapter discusses the ICH-GCP guidelines on obtaining informed consent from subjects. The highlights include the need to use non-technical language, transparently delineate risks, obtain consent without undue influence, obtain consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to ensure that subject trial data (as recorded in Case Report Forms or CRFs) correspond to source data (previous medical records).

This module provides a detailed overview of the structure and elements of a Case Report Form (CRF), including different forms for Principal Investigator (PI) verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events, etc. Additionally, the chapter outlines important data notation rules, such as the use of accepted acronyms (e.g., ‘ND’ for missing data and ‘UNK’ for unknown information), MM-DD-YY format, time-stamp data, etc., as well as guidelines for the design of CRFs (e.g., consistency of notation, avoidance of duplicate data fields).

In this unit, you will learn about Quality Control in clinical trials. This includes understanding what Quality Control is, its relationship with Quality Assurance, using Key Performance Indicators, having a Corrective and Preventive Action plan, and more. Additionally, the module will look at the QA process, focusing on risk-based monitoring and providing guidelines on Quality Metrics. The chapter also reviews ICH-GCP guidelines on subject safety, including risk-benefit assessment and stoppage rules in case of serious adverse events. Finally, it introduces the FDA’s Human Research Protection Program.

This tutorial provides an in-depth look at the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs), including IVRS and IWRS, as well as RTSM systems for Randomization and Trial Supply Management are examined. The benefits of standardized data management and data sharing, approaches to database management, and the concept of an Independent Data Monitoring Committee (IDMC) are reviewed. Critical elements of data integrity, such as proper anonymization and coding, completeness of data, data safety precautions, and logging of site visits and other progress reports are highlighted Essential features of a good Clinical Data Management(CDM) system that complies with FDA CFR Title 21and HIPAA regulation.

This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements.

This unit will teach you about pharmacovigilance (PV), which is the process of monitoring the effects of drugs. You will learn about the statistics on adverse events (AEs), how to distinguish between Type A and Type B AEs, and how to assess the severity and probability of an adverse drug reaction (ADR). This unit also covers Individual Case Safety Reports (ICSRs) in detail, including their structure, content, and role in trial monitoring. Other topics include types of PV inspections, periodic safety update reports (PSURs), and study criteria for instituting data safety management boards (DSMBs).

In this chapter, we provide a detailed review of the protocol for receiving, storing and dispensing the investigational product (IP). At every stage, there are guidelines in place to ensure the safety of study subjects and staff. This includes handling the IP with care, logging relevant information such as date of manufacture and batch number, and recording shipping details. Additionally, we address the need for precautions when dispensing the IP, such as limiting access to authorized personnel only.

This section looks at how lab testing in clinical trials has changed over time. It used to be done in local labs, which had a lot of mistakes. Now it is done in central labs, which makes it more accurate and reliable. The section also covers standards for clinical trial laboratories, such as the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments). Additionally, it provides guidelines for lab audits, including fire safety and staff training.

The chapter reviews essential documentation that needs to be created and maintained throughout the clinical trials. This includes the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312. You will learn about each of these forms and why it is important to keep records updated, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. The unit also requires that you submit documents that describe the procedures for the study and site, including an SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR). This includes Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56), Series on food (100), pharmaceuticals (200 and 300), as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES). Part 11 lays down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

This module will cover the process of how drugs are evaluated by the FDA, and the role of a CRA in this process. You will learn about the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The criteria for evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, you will learn about FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators.

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF.

In this chapter, we will discuss FDA guidelines regulating financial disclosure in depth. This will cover the definition of 'conflict of interest' and the stipulations of Title 21 Section 54 on disclosure requirements. We will also study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on 'fair market value' as well.

The chapter also talks about things that might make it hard to meet recruitment goals, and how to make it easier, like being less picky about who can join, giving people money to cover travel costs, and making it clear what benefits come from participating. The unit also covers why patients might leave a trial early, and how to prevent that from happening as much, like making the experience better for patients (by paying more attention to them and being flexible with when they can come in for visits, etc.), and using technology to make things simpler and more efficient (like having digital forms that can be completed automatically). Finally, the unit discusses some new ways of keeping patients involved and compliant in clinical trials; these techniques use technology to get better results.

This module discusses reasons why people might commit scientific fraud, and the consequences of fraudulent practices in clinical trials. A scale is presented for classifying errors in clinical trial data. At one end of the spectrum is ‘honest, isolated mistake’ and at the other end is ‘deliberate data falsification with malicious intent’. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will learn how to identify signs of fraud during the actual clinical trials process.