Clinical Research FAQs
See below for our most frequently asked questions. If the information below doesn't answer your questions, please email us at email@example.com.
- Join SoCRA - this will allow you to begin networking and understand the roles in clinical research. You will receive four SoCRA Source magazines per year and the opportunity to attend our annual conference, which has educational sessions at a reduced rate.
- Attend our educational programs beginning with the Clinical Science Course which is a five day workshop aimed at those new to the field and those wanting a refresher. See Educational Workshops for more information.
- Certification is recommended. If eligible (see Certification for more information), the member will have the opportunity to sit for the certification exam. For those not eligible, the opportunity will still be there when they meet eligibility requirements. A study guide is available and this is a good reference tool to have even if not taking the exam. The cost is $50.00 if purchased separately, and it is included in the cost of registration to take the examination.
- Subscribe to Applied Clinical Trials (web site www.actmagazine.com) and perhaps Research Nurse (web site www.researchnurse.com). Both journals are excellent in the way of educating the clinical research professional and introducing the reader to the many career opportunities.
- Internet: Do your homework... browse and read about clinical research companies, associations, latest technologies and other like organizations to keep up with what is going on in the field.
- Lastly, talk to others in the field and ask them what they do and how. Become familiar with all the different aspects of clinical research and position yourself to be "in the know."
There are a lot of paths to become a CRA. Depending on where you are in your career, you may wish to begin networking with individuals in your area who are already working as a monitor. You could also become a SOCRA member and take advantage of the online membership directory to email other research professionals in your area. You can apply for membership here. Individuals already working in the field can give you the best advice regarding local training and employment opportunities.
You could also consider attending our Monitoring + GCP Workshop. It is taught by two subject matter experts that have a lot of valuable information and are available to speak with and advise attendees. Find more information about this course here.
There is also a monitoring track at our upcoming annual conference in September in Las Vegas. Find more information about the Annual Conference here. The agenda will be posted in the summer.
We also offer a SOCRA CCRP Certification for Clinical Research Professionals. It is not specifically a CRA certification, but encompasses all of the industry regulations and guidelines that CRPs operate under. For more information, click here.
SOCRA members work in all fields of research. Across fields, a common bond exists among those who are involved in clinical research. With changes occurring daily in the health-care field, we must all stay abreast of the latest developments and practices which affect us and our work. SOCRA membership provides opportunities for education, networking, and career growth. Membership is available to all clinical research professionals who work with cooperative research groups, academic, government, and private institutions, pharmaceutical and biotechnology companies, device manufacturers, CROs, SMOs, independent research and development organizations, and those who are involved in the management of clinical trials.
You can apply for SOCRA membership using the link below: https://www.socra.org/membership/applications-and-renewals/apply-for-new-membership/
Membership fees ($75 USD/year) are processed immediately and are not refundable or transferable. The membership packet / receipt is mailed at the beginning of the following month in which payment is received.
Belonging to SOCRA, a professional organization with more than 16,000 members, provides you with the information and resources you need to advance your career and enhance your professionalism. Membership benefits include access to the following:
High Quality Professional Education
Global Network of over 16,000 clinical research professionals
Local Education through SOCRA Chapter Network
For details on the top reasons to belong, follow the link below: https://www.socra.org/membership/member-benefits/
SOCRA is a membership organization and relies on its membership involvement and support to help the society grow. Members are encouraged to become actively involved as speakers for our educational courses, poster presenters at the Annual Conference Poster Program, as authors in the SOCRA Source Journal, volunteer board member and numerous other activities. By working together we can ensure that SOCRA meets the needs of the industry. For more information visit our website using the link below or contact our office at firstname.lastname@example.org.
SOCRA conducts a salary survey every 5 years. Our last survey was conducted in 2015, and those results are available at no cost here. We will begin preparing our 2020 survey next year.
You also can refer to www.salary.com, where you can select a position and location and receive the latest results of their studies.
There are some helpful links below that can give you information about the SOCRA certification program and exam. Please review and contact our office if you have any questions. You reach our Certification department by email at email@example.com or by calling our office at 215-822-8644.
You can apply early (up to 3 months) and will be pre-approved pending confirmation by your employer that you are still employed as a clinical research professional at the time of the exam. Please contact our Certification department if you have any questions by emailing firstname.lastname@example.org or by calling our office at 215-822-8644. For more information on the CCRP exam application, visit the link below:
SOCRA hosts over 90 paper and pencil exams each year across the U.S. and Canada. You can find the exam schedule for SOCRA sponsored sites using the link below:
We are always adding exam dates and locations to our SOCRA hosted schedule so feel free to check back periodically.
Please note that computer based testing/retesting is now available at area test centers. There is no need to wait a lengthy period or travel to a sponsored site on the exam schedule. If needed, you can take a look at your local centers using the linke below:
Under Select Organization, select Certification/Professional Orgs. Under Select Sponsor, scroll down and select Society of Clinical Research Associates. Under Select License, select CCRP then hit Continue at the bottom of the page.
For more information on Computer Based testing visit the link below: https://www.socra.org/certification/ccrp-certification-exam/computer-based-testing/
To prepare for the exam, a candidate should study the detailed exam outline (link below) and consider the knowledge, skills, and abilities needed to perform the duties of a clinical research professional (CRP). Satisfactory completion of the CCRP® certification examination indicates that the candidate has met all the eligibility criteria and has demonstrated knowledge of the key duties/tasks of a CRP.
Candidates can find the exam outline using the link below:
For an overview of preparing for the exam, visit the link below:
We do not have a practice test, but the link above provides sample questions.
Additional resources can be found using the link below: http://www.socra.org/certification/ccrp-certification-exam/preparation-resources/
Please remember that the examination assesses your knowledge and understanding of the United States Code of Federal Regulations and the International Conference of Harmonisation E6 & E2A Guidelines. It does not assess state, local, provincial, Ministry of Health, or institutional policy. Additionally, you will not be asked regulation numbers. However, you should be very familiar with the content of the regulation, especially regarding timelines for compliance. You should know who needs to be reported to and when given a particular circumstance . And you should be clear what FDA requires, especially if your company SOPs differ – even if they are more stringent. You should always answer based on what FDA requires.
SOCRA chapters are designed to help SOCRA members obtain CE towards Recertification at no cost. For that reason we do ask that the chapter chair person be CCRP certified so that they can help answer questions from members or perspective members about SOCRA and the exam process. There are no dues or fees and no money should exchange hands so there is minimal paperwork as we try to keep the process as simple as possible.
As chapter chair, your main responsibilities are getting a speaker, a room and giving us the announcement to review and distribute to the geographic area you specify.
If you’d like to move forward with starting a Chapter please email email@example.com. and request a copy of our SOCRA Chapter Policy and Toolkit. For more information on chapters or to find a chapter near you, visit the link below:
You can offer SOCRA CE’s for your upcoming educational program, event, or conference. SOCRA doesn't "approve" other education, however, we try to keep it as simple as possible. As long as the education you offer pertains to research regulations, operations and management, and is also specific to the therapeutic area of research in which the candidate participates, it can be used for SOCRA recertification.
In order for SOCRA to accept CE’s for this program, attendees would need a certificate of attendance. On the certificate, you would need to add the following: "The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers __ hours of CE credit."
Contact us a firstname.lastname@example.org with any questions.
Below is a list of various ways you can acquire CE as a SOCRA Member.
SOCRA Source Self Studies: To receive CE you can complete the SOCRA Source Self Studies included in each issue of the SOCRA Source mailed to you on a quarterly basis (4 issues per year). You may earn 1 CE each in the Regulatory category for a maximum of 12 credits. (free of charge – Source issues are complimentary with SOCRA membership)
Annual Conference Opening Plenary Sessions: We record Opening Plenary Sessions at SOCRA’s Annual Conference each year. These sessions can be found on the SOCRA YouTube Channel – https://www.youtube.com/c/socra. If you do choose to review these sessions for CE, a summary of studied material (minimum 250 words) is to be submitted. Recordings must be one hour in length for each hour claimed. (free of charge)
Collaborative Institutional Training Initiative (CITI) Program: CITI is a collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to develop a web based training program in human research subject protections. SOCRA has joined CITI to offer SOCRA members free entry-level basic courses in the areas listed below. (free of charge for SOCRA members)
Human Subjects Research – up to 9 CE
Good Clinical Practice (GCP) – up to 13 CE
Health Information Privacy and Security (HIPS) – up to 3 CE
Responsible Conduct of Research (RCR) – up to 4 CE
How to enroll in a CITI Program: https://www.socra.org/membership/member-benefits/citi-program/.
CITI - SOCRA Quick Reference CE Chart: https://www.socra.org/assets/Certification/CITI-COURSES-for-SOCRA-CE.pdf
SOCRA Online Courses: For $35.00 per 1 CE, SOCRA offers online courses covering various topics relevant to Clinical Research Professionals including: What You Should Know Before the FDA Arrives, ICH E6 (R2): From the Site’s Perspective, IND/IDE Assistance, cGMP for Investigational New Drugs (IND) in Phase 1 Clinical Trials, Risk Based Monitoring from the Site Perspective and many more. ($35.00 per 1 CE credit)
See a list of online course offerings: https://www.socra.org/conferences-and-education/clinical-research-courses-online/
SOCRA Live Conferences: SOCRA offers a robust portfolio of live conferences, workshops, and courses to keep you at the forefront of the industry and support your continuing educational goals. (cost for each course varies)
See all live course offerings: https://www.socra.org/conferences-and-education/training-conferences-workshops-courses/
See the events calendar for upcoming courses: https://www.socra.org/conferences-and-education/events-calendar/
FDA Training: Visit the FDA links below to complete the trainings they have available. (free of charge)
FDA Continuing Education Courses: https://www.fda.gov/Training/ForHealthProfessionals/ucm545645.htm
FDA Overview of Biosimilar Products – 1.5 CE
Drug Efficacy, Safety, Quality, and Beyond – 1.5 CE
Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemic Events in Patients with Type 2 Diabetes – 1 CE
Device FDA Continuing Education Courses: https://www.fda.gov/Training/CDRHLearn/default.htm
National Drug Abuse Treatment Clinical Trials Network (NIAID) Learning Center: NIAID offers GCP training. This training is separated into 4 parts and offers 4 CE. (free of charge)
NIAID GCP Course: https://gcp.nidatraining.org/
Many IRBs have webinars on their websites as well. (For example, Quorum and Forte): If you do choose to review these sessions for CE, a summary of studied material (minimum 250 words) is to be submitted. (free of charge)
**For any course, training or webinar that does not provide a certificate upon completion, a summary of studied material is to be submitted (minimum 250 words) in lieu of the certificate.
We have a simple online process for requesting receipts. Please visit the link below to complete the form to request a receipt:
If you have any other issues with the receipt, you can contact our Accounting Department at email@example.com or by calling our office at 215-822-8644.
The certification period is three years, beginning on the date of most recent certification and ending on the certification expiration date. All CE must be accrued during this time period. Certificants must have completed 45 hours (45 credits) of CE during their certification period. A minimum of 22 CE must be related to Clinical Research regulations, policy, etc. The remaining CE may relate to your Therapeutic or Professional Area. 1 CE will be awarded for the successful completion of the recertification continuing competence learning module. Only educational hours may be claimed for CE; you may not claim CE credit for your work hours. In order to maintain active certification status, the CCRP® must apply for renewal of certification to the Certification Committee every three years. For more information, visit the link below:
We offer a robust portfolio of live conferences, workshops, and courses to keep you at the forefront of the industry and support your continuing educational goals. Visit the link here to take a look at upcoming courses happening near you. We also offer the SOCRA chapter program designed to offer colleagues a way to acquire continuing education credit for SOCRA CCRP recertification and to become involved with SOCRA’s local educational programming. Such programming is of no cost to SOCRA members. Check out the link here to find a local chapter near you or email us at firstname.lastname@example.org to find out how you can start one!