How to Choose Qualified Clinical Research Associates

Clinical trial sponsors are responsible for ensuring clinical trials are properly monitored to meet regulations, protocol compliance, regulatory adherence as well as patient’s safety, privacy, rights and welfare. A Clinical Research Associate (CRA), also called CRA, Clinical Trial Monitor and Monitor, is hired to perform this task. The CRA's main objective is to assess the clinical trial performance at the principal investigator’s clinical site to ensure compliance is observed. This article provides steps sponsors should take to ensure the Clinical Research Associate is qualified to monitor the clinical trial.

Difficulty: Moderate

Instructions

Things You'll Need:

• Basic knowledge about clincal research
• Computer
• Internet access

1. 

   Create a Job Description and Advertise.
   
   Post the job description and career opportunity on job listing websites such as HireRx.com, Hirebio.com, LinkedIn.com, Hotjobs.com, Monster.com, and careerbuilders.com for a Clinical Research Associate.

2. Determine the CRA's medical and GCP knowledge.
   
   Review the Clinical Research Associate’s curriculum vitae (CV) to determine if the person has basic science or medical experience. This is not a regulatory requirement, but depending on the disease being investigated, it is wise to ensure the CRA knows enough about science to do a good job.

3. Verify monitoring experience.
   
   Confirm that the Clinical Research Associate has experience monitoring clinical trials. Do not assume the CV is accurate. Ask specific questions during the interview to ascertain the candidate’s knowledge and learning potential.

4. Ask questions related to GCPs.
   
   Assess the Clinical Research Associate’s knowledge of Good Clinical Practices (GCPs) and confirm that they have not been debarred by the Food and Drug Administration for poor performance on previous clinical trials

5. Assess CRA's people's skills.
   
   The Clinical Research Associate acts as a liaison between the sponsor and the clinical investigator’s site. Therefore, the Monitor must be able to develop amicable working relationships with sites’ staff. this is a challenge for many who have a low tolerance level for over-worked or naturally irritable research coordinators.

6. Get samples of CRAs writing.
   
   Assess the candidate’s verbal and documentation skills. Ensure they can accurately document clear observations in a report format. Ensure they know to follow-up with issues until all are resolved.

7. Discuss travel time.
   
   Confirm that the Clinical Research Associate is able and willing to travel (e.g. 80% of the time or as needed) and put in the time needed to perform the task to the end of the trial.

Resources

• How to Coordinate a Successful Clinical Trial Collaboration
• How to Get Certified as a Clinical Research Associate
• How to Choose a Good Research Study Coordinator

[Limowreck]

on 6/22/2008 Highly useful information. Well written. Love the stats. 5 stars!