What Is A CRA

Question 1

What is a CRA?

Answer 1

A Professional (typically home -based) who oversees/supervises all aspects of clinical trial conduct.

Also know as a trial monitor/monitor or site manager

Liaison between sponsor and the PI

CRA’s work in various settings such as pharmaceutical companies , Clinical Research Organizations (CRO’s) medical research institutes and government agencies.

Question 2

CRA Requirements

Answer 2

Previous industry experience 
High School Diploma/GED
No criminal convictions w/in 7yrs
Pass Drug Screen (Urine)
Valid DL

Willing to travel up to 70%
Well Organized
Multi-Tasker
Excellent written and verbal communication skills

Question 3

CRA RESPONSIBILITIES

Answer 3

• Conduct on/offsite visits
• Conduct protocol/study training
• Ensure that site staff is qualified by training and experience
• Ensure subjects’ privacy, safety and well being
• Review subject data
• Review Essential Documents
• Complete Trip reports (reports that CRA’s give after every monitor visit (PSV/PSSV, SIV, IMV/RMV, COV) to deliver to their lead CRA and ultimately get to the Sponsor for the Sponsor to APPROVE the report. A detailed summary of everything that happened during their monitoring visit. It also serves as a foundation for the follow up letters (FOL)that the sites will receive b/c the sites will never see the reports but they will see the FOL and then both go into the Trial Master File (TMF) after every visit.)
• Site communications/guidance

Question 4

CRA VALUE

Answer 4

• Play a role in study conduct and quality
• Principal role in monitoring the progress of a trial
• Main defense against data errors during the clinical trials
• Major impact on the timely completion of trials
• Vital role in ensuring that