Changing Role of a CRA

CRA Responsibilities

A clinical research Assure the protection

Perform
associate ensures of the rights, safety
investigational product
compliance with and well being of
accountability.
the trial protocol. subjects.

Ensures that the

Communicates scientific integrity of
Checks clinical site
with clinical research the data collected is
activities.
coordinators. protected and
verified" .

Makes on-site visits Assure that adverse

(during setup, conduct Reviews case report events are correctly
and closeout of a forms (CRFs). documented and
trial). reported.
Prior to EDC
Timeout!
Automation
Edit-checking CRFs
Manually querying sites
source data verification
 Remote
monitoring
Qualification
SPONSOR
FREELANCER