Certification Program for the Clinical Research Professionals©
CertCR (Certified Clinical Research Professional)
Table of Contents
Certification Program for Clinical Research Professional
The Clinical Research Institute of America has developed a unique certification program that is flexible and accessible to all clinical research professionals and new professionals seeking to acquire the highest quality of clinical research knowledge and recognition in the industry. We offer as part of the Certification Program, a complete training and education program to allow participants to focus on learning and achieving the highest professional standards. The Certified Clinical Research Professional is going to have access to broader job market, and will meet employer’s needs more efficiently. Although certification is not mandatory to work in the industry, it has become conclusive.
The Clinical Research Institute of America will assist you to achieve your certification at your pace and with full support from our professional instructors. We provide you with full training.
For clinical research professionals who wish to access the certification exams without previous participation to our training programs, they may do so. Please refer to Certification Exams.
CertCR – The Certified Clinical Research Professional
The Certification of the Clinical Research Professional is an acknowledgement to science and other health related professionals that they have achieved the expected professional standards and have fulfilled all the requirements established by the Institute in relation to clinical research.
Certified Clinical Research Professional has demonstrated through training and experience that has the necessary knowledge and background to perform activities and assume responsibilities established by the FDA 21 CFR 312, 50, 54 & 812 and ICH-GCP.
The Certified Clinical Research Professional is prepared to work with the sponsor and the investigator of a clinical study with a sound knowledge of clinical research ethics, rights and responsibilities.
The Clinical Research Institute of America developed a unique certification process. The Institute will prepare the candidate in all established areas. The eligibility criteria are flexible enough to allow access to all qualified professionals interested in becoming a Certified Clinical Research Professional.
We take into account that the candidates are busy professionals that do not have the luxury of spending time figuring out the regulations and requirements through web based training, books or handouts. For that reason, the candidate participates in three training sessions, after each training session, a detailed exam will be taken. Each session will prepare the candidate to the next level of comprehensive knowledge.
All eligible candidates can go through the process in a time and resource effective manner, and the Institute provides all necessary training and materials to achieve certification. The certification process of the Clinical Research Institute of America involves 3 steps.
After each step is achieved, the participant will receive a certificate that represents the achievement, and when he/she reaches the step-3 together with the established requirements, full certification is granted.
Step 1- CertCR Program
To participate in the Step 1 of the certification process, the candidate must have a minimum of:
- Bachelors of Science degree or
- Bachelor of Arts in a related discipline or
- Registered Nurse
- No experience in Clinical Research is required at this point.
- All candidates must register with the Clinical Research Institute of America and pay a $150 non-refundable fee.
- Upon registration a candidate number is provided together with a schedule of the training courses
- Next, the candidate enrolls to the first training course “Good Clinical Practices – Comprehensive Program (A001)” according to their own availability.
- The candidate must participate to the 2 full days sessions and at the end of the second day, the candidates will take a comprehension exam
- Upon satisfactory completion of the exam the candidate will receive the certificate Step 1 that counts towards the CertCR certification. Examination results will be mailed to the candidates. If the candidate did not achieve the minimum expected requirement of 75%, a certificate of attendance will be issued and the candidate will have the opportunity to participate to the exam in the next scheduled date (an exam fee applies).
Step 2-CertCR Program
To participate in the Step 2 of the certification process the candidate must pass step 1. Although no formal experience in Clinical Research is required, the candidate is encouraged to start participating actively in clinical research activities.
- Upon completion of Step 1, the candidate is prepared to attend to the training session “Monitoring Clinical Trials (A006)”. This is a 2 day workshop where the candidate will walk through the process of monitoring clinical trials, data transfer and verification as well as resolution and regulatory compliance. Source documentation and electronic systems as well as 21 CFR 11 and its impact in clinical research will be discussed.
- The candidate must participate to the 2 full day sessions and at the end of the second day, the candidates will take a comprehension exam.
- Upon satisfactory completion of the exam the candidate will receive the certificate Step 2 that counts towards the CertCR certification. Examination results will be mailed to the candidates. If the candidate did not achieve the minimum expected requirement of 75%, a certificate of attendance will be issued and the candidate will have the opportunity to participate to the exam in the next scheduled date (an exam fee applies).
- At this point the candidates are encouraged and also provided with opportunities in clinical research to achieve the next level.
To participate in the Step 3 of the certification process, the candidate must pass Step 2, and be actively working in clinical research.
- Upon completion of Step 2, the candidate is prepared to attend to either or both of the training sessions :
- Course 1: “The Clinical Research for the Clinical Research Coordinator – (A004)” a 2 day intensive program. The Clinical Trials Coordinator program includes training in every activity the coordinator will be involved during a clinical trial at an investigator site. The program includes the complete process of clinical trials and drug/medical device development in the industry and academia. The course is based on ICH/GCP (Good Clinical Practices) for Clinical Research, and FDA/Health Canada Requirements.
- Course 2: “The Patient Information and Consent Process – (PIC01)” a 2 day intensive program that will present the issues of obtaining a fully ethical and compliant consent. This is a practical course where also professional clinical research volunteers that will pose as patients will recreate the scenarios of consenting. This is a 2 day learning experience that will allow investigators understand and apply immediately the knowledge acquired.
- The candidate must participate to the 2 full day sessions and at the end of the second day, the candidates will take a comprehension exam
- Upon satisfactory completion of the exam the candidate will receive the certificate Step 3 that counts towards the CertCR certification. Examination results will be mailed to the candidates. If the candidate did not achieve the minimum expected requirement of 75%, a certificate of attendance will be issued and the candidate will have the opportunity to participate to the exam in the next scheduled date (an exam fee applies).
To Complete the CertCR Certification Process
To complete CertCR certification, the candidate must have completed all the three steps satisfactorily. Also, the candidate should have at least 1 year of combined experience in clinical research as coordinator, monitor, or in other related function. The experience should be documented in form of a letter issued by an employer /institution where the candidate participates as a clinical research member.
Certification process schematic diagram
Maintenance of the CertCR Certification
Every year the Certified Clinical Research Professional (CertCR) has to complete a refresher program with the Institute. The courses eligible will be listed in www.criamerica.com. Those courses are prepared to refresh and to update physicians on new regulatory and practical issues in clinical research. An on-line maintenance program is also being developed to allow flexibility. Also, in the future the maintenance program will accept contact hours provided by other continuing medical education institutions as they become available.
The candidate to the Certification Program will incur in the following fees:
||150.00 (non refundable)
|Course Step 1
|Course Step 2
|Optional course Step 3
|Exam retest fee
|Certificate reissue (copy)
*Course fees may be less, since early-registration may allow the participant save up to 30% of the original cost
**Certification maintenance courses are 1 day refresher programs; although the CertCR holder may take any other related course offered by the Institute and pays the corresponding fee.