Clinical Research Certification - CCRA, CCRC, CPI

Gaining a clinical research certification can offer many benefits for those in the field. Earning a credential through a rigorous application review and exam 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. In addition to enhancing one’s job prospects at medical research institutes, pharmaceutical corporations, and government agencies, having a national certification can also qualify a person for leadership roles. 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 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 protection of human subjects, compliance with research regulations, and 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.

The George Washington University (Health Sciences)
Online MSHS - Clinical Research Administration
Online MSHS - Clinical & Translational Research
Arizona State University
Clinical Research Management (MS)
Clinical Research Management - Regulatory Science (MS)
Johns Hopkins University (AAP)
MS - Biotechnology
MS - Regulatory Science
*sponsored

Certified Clinical Research Associate (CCRA)

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

Eligibility Requirements: Applicants must provide proof of the following through a job description, curriculum vitae, or other documentation:

  • They work independently of the investigative staff conducting research at the organization, which means they do not report to the PI or site manager and that they cannot change or manipulate data.
  • They work on behalf of a sponsor such as a pharmaceutical company, device company, grant company, university, sponsoring physician, or other entity, in the role of an independent monitor.
  • They have performed all of the CRA essential duties for the required number of minimum hours depending on their level of education and work experience:
    • Bachelor’s Degree or Higher: 3,000 cumulative hours performing essential duties and all required documentation of those duties through a detailed resume/CV and a job description
    • LPN, LVN, RN, or Associate’s Degree: 4,500 cumulative hours performing essential duties and all required documentation of those duties through a detailed resume/CV and a job description
    • Medical Assistant, Lab Technician, High School Diploma, or Other: 6,000 cumulative hours performing essential duties and all required documentation of those duties through a detailed resume/CV and a job description
    • One Substitution May Be Applied:
      • Current CCRC or CPI Designation: Applicants may subtract 1,500 hours of essential duties from the above options.
      • Completion of Clinical Research Education Program: Applicants who have completed a clinical research education program that meets ACRP requirements may subtract 1,500 hours of essential duties from the above options; certain submission requirements apply

All applicants undergo a formal eligibility review process upon application.

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

  • Scientific concepts and research design
  • Product development and regulation
  • Participant safety and ethical considerations
  • Data management and informatics
  • Clinical trial operations
  • Study and site management

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 on the basis of 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 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.
  • Exam Dates: Spring 2018 exam dates are February 22 through March 20.

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
  • LPN
  • RN
  • LVN
  • Research Nurse
  • Independent Consultant/Contractor

Certified Clinical Research Coordinator (CCRC)

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

Eligibility Requirements: Applicants must provide proof of the following through a job description, curriculum vitae, or other documentation:

  • They have performed all of the CRC essential duties such as reporting and documenting safety issues, participating in conducting subject visits, collecting accurate and verifiable data and documents, among others, for the required number of minimum hours depending on education and work experience:
    • Bachelor’s Degree or Higher: 3,000 cumulative hours performing essential duties and all required documentation of those duties through a detailed resume/CV and a job description
    • LPN, LVN, RN, or Associate’s Degree: 4,500 cumulative hours performing essential duties and all required documentation of those duties through a detailed resume/CV and a job description
    • Medical Assistant, Lab Technician, High School Diploma, or Other: 6,000 cumulative hours performing essential duties and all required documentation of those duties through a detailed resume/CV and a job description
    • One Substitutions May Be Applied:
      • Current CCRA or CPI Designation: Applicants may subtract 1,500 hours of essential duties from the above options
      • Completion of Clinical Research Education Program: Applicants who have completed a clinical research education program that meets ACRP requirements may subtract 1,500 hours of essential duties from the above options; certain submission requirements apply

All applicants undergo a formal eligibility review process upon application.

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

  • Study and site management
  • Scientific concepts and research design
  • Product development and regulation
  • Data management and informatics
  • Clinical trial operations
  • Participant safety and ethical considerations

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 Format: 125 multiple choice questions that test knowledge on the basis of 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 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.
  • Exam Dates: Spring 2018 exam dates are February 22 through March 20.

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 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
  • RN
  • LVN
  • LPN
  • Research Nurse
  • Independent Consultant/Contractor

Certified Principal Investigator (CPI)

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

Eligibility Requirements: Applicants must provide proof of the following through a job description, curriculum vitae, or other documentation:

  • They have a doctorate degree (DDS, MD or equivalent) or are a licensed physician’s assistant or nurse practitioner who has served in a PI role
  • They have served as a Principal Investigator for two of the last five years
  • They have performed all of the CPI essential duties such as being responsible for the safe and ethical conduct of a clinical trial, as well as communicating with subjects, CPAs, and the institutional review board, among others, for the required number of minimum hours
    • One Substitution May Be Applied:
      • Current CRA or CRC Designation: Applicants may subtract 1,500 hours of essential duties from the above requirements
      • Completion of Clinical Research Education Program: Applicants who have completed a clinical research education program that meets ACRP requirements may substitute the program for one of the two required years of employment as a PI; certain submission requirements apply

All applicants undergo a formal eligibility review process upon application.

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

  • Scientific concepts and research design
  • Participant safety and ethical considerations
  • Product development and regulation
  • Clinical trial operations
  • Data management and informatics
  • Study and site management

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”.

  • Exam Format: 125 multiple choice questions that test knowledge on the basis of 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 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.
  • Exam Dates: Spring 2018 exam dates are February 22 through March 20.

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.

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:

  1. Two years of experience as a full-time clinical research professional or 3,500 hours part-time experience during the last five years
  2. Associate, undergraduate, or graduate degree in clinical research and has a minimum of one year of full-time experience or 1,750 hours part-time experience during the past two years as a clinical research professional
  3. 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 degree in a pharmacy, science, health science, or related field; and a minimum of one year of full-time experience or 1,750 hours 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, signed ethics statement.

Exam Details: The exam focuses on five content areas patterned after the 2012 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: 135 multiple choice questions that assess understanding and application, five of which are beta testers and are not scored. Examinees must answer 102 of the 130 scored questions correctly to gain certification.
  • Exam Duration: Maximum of four hours
  • Exam Delivery: Paper and pencil format or computer-based testing
  • Exam Language: English
  • Exam Fees: Payment in full or three year payment plans available; upon successful completion of the test, certified individuals receive three years of membership with any form of payment. Please note that there is a reduced retest fee for retaking the test within one year.
    • 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 be in relation to the professional’s specific career path.

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

Certified Research Administrator (CRA), Certified Pre-Award Research Administrator (CPRA), 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:

  1. 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
  2. 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
  3. 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

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: 250 multiple choice questions
  • Exam Duration: Maximum of four hours
  • Exam Delivery: Computer based testing at certified PSI testing facilities
  • Exam Language: English
  • Exam Fees:
    • CRA: $385; $100 international test center fee additional
    • CPRA and CFRA : $375; $100 international test center fee additional
  • Exam Dates:
    • CRA: Spring – May 12-26, 2018; Fall – November 3-17, 2018
    • CPRA: Spring – February 10-24, 2018; Fall – August 11-25, 2018
    • CFRA: Spring – March 10-24, 2018; Fall – September 8-22, 2018

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.

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:

  1. Holds a bachelor’s degree or higher and has a minimum of two years full-time clinical data management experience
  2. Holds an associate’s degree and has a minimum of three years full-time clinical data management experience
  3. Has four or more years full-time clinical data management experience
  4. 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 Language: English
  • 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 Prometric. Once requested, Prometric will make every effort to provide candidates an exam within 50 miles and 30 days of the requested date and location within the U.S. and Canada, and within 100 miles and 30 days outside the U.S. and Canada.

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 the validation of a specific skill set and knowledge which certifies them as an expert 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.