Responsibilities Of A Cra

Responsibilities of a CRA Dr.Pratibha Nadig ICRI,Bangalore

Clinical research associate  Key person in the clinical trial  Major link between the sponsor and the investigator  Performs both Clinical operations as well as monitoring

Clinical research associate o Appointed by

the sponsor or CROs Work independantly

 Location -Inhouse CRAs or field CRAs  Levels- Upto 4

CRA levels  The levels are decided by the experience  With experience a level 1 CRA will move to higher levels depending on  Ability to evaluate a potential site with expertise,experience and patient resources,  Better understanding of the scientific method  Recognize the actions and procedures that would bias the study and invalidate the data

1.STUDY PLANNING  Write and edit protocols for clinical studies  Co-ordinate review of protocol  Write and review informed consent forms  Identify and evaluate CROs.  Identify and evaluate the Central labs.

2.DEVELOPMENT  Write and review sections of IND  Design and develop CRFs  Help in writing Ibs  CRF Instruction manuals  Determine the requirement,order, ship and track the investigational drug supplies  Evaluate and select the investigators

2.DEVELOPMENT  Pre-study visit at the investigational sites  Plan the investigators meetings and present sessions  Review the investigators contracts  Develop study budgets and the payment schedules  Write and review protocol amendments

3.STUDY CONDUCT  Write and review annual IND reports  Update the investigators brochure  Conduct study initiation visits  Conduct routine monitoring visits  Oversight of CRO activities  Mentain and track the study data  Assist in data review and correction

3.STUDY CONDUCT  Review assess and interpret the study data

Monitor and report adverse events  Review the regulatory documents

4.CLOSE OUT  Conduct the study close out visits  Perform post study follow ups

5.POST STUDY  Write and review the final study reports  Archive the study files  Assist with writing and reviewing sections of NDA  Assist in response to any FDA inspections

OTHERS  Train and mentor new people  Act as a project manager