MRM, a leading provider of research education and customized training, is pleased to announce the Clinical Research Associate (CRA) Fellowship program™. MRM has over 10 years experience in training CRAs in using a systematic monitoring method to secure GCP compliance through both Corrective and Preventive Action (CAPA) plans. MRM has been the leader in creating and launching the 140 CRA Certificate program; participating in an OHRP sponsored conference at the University of Pennsylvania as part of a panel to discuss methods for better protecting the rights of study participants, trained at NIH, and at ACRP conferences.

Avoid These Monitoring Issues!

• Limited selection of CRAs
• High turnover rate
• Not formally trained
• Lack of GCP ICH application expertise
• "Post-It Note" monitoring
• High priced but, provides poor monitoring quality
• Does not monitor using a standard approach and monitoring tools
• Poorly written reports or reports with limited documentation
• Does not meet deadlines or submit reports on time
• Poor work ethic and follow-up

The MRM CRA Fellowship Program™ is an innovative program that provides carefully selected, trained, and competency tested clinical research professionals to monitor clinical studies. It is a two year program that is 40-50% less than the typical contract monitor or large CRO costs. The Fellowship provides CRA stability, cost savings and quality monitoring all at the same time.

The applicant is a graduate of the 140 CRA Certificate program that is part e-learning and two weeks of hands on monitoring across two protocols. Graduates selected to apply for the fellowship are recommended to have achieved an 80% passing score of the following:

• Monitor Competency Exam
• FDA GCP & ICH GCP Exam
• Fundamentals of Clinical Research Exam

Applicants are pre-screened using behavioral interviewing techniques and a monitor report writing activity. This activity can be customized to your organizations processes. This aids in assessing the CRA’s compatibility with your organization. The Fellows are paired with an MRM Clinical Monitoring Mentor (CMM). The CMM has greater than 5 years monitoring experience and has received "Train the Trainer" training. The CMM accompanies the Fellow on a training performance evaluation visit. This is a structured documented visit that includes assessment tools, trainee instructional guide, and CMM leader's guide.

This visit can occur with your organization or may occur on a different protocol. The CMM acts as a mentor during the two year fellowship; this includes reviewing reports to assess ongoing quality, and reviewing monitoring tools for completion. To enhance knowledge, experience, and maintain cutting edge monitoring strategies, the Fellows are required to research FDA Warning letters summarizing their findings in quarterly GCP ICH roundtable discussions. They must present strategies to correct and prevent such deficiencies.

• Graduate of the MRM 140 CRA Certificate Program
• BS/BA, or MA/MS or, MD, Ph.D, or RN
• Competency Tested
• Knowledge Tested
• Performance Evaluation

• Over 5 years Monitoring Experience
• Attended a "Train the Trainer"
• Evaluated as a Trainer by MRM
• Attended MRM Monitoring Method Seminar