JOB DESCRIPTION FOR CLINICAL RESEARCH ASSOCIATE I

Responsibilities:

 Identify and recruit investigators.

 Conduct on-site clinical monitoring which includes: document review, ensuring
accurate data recording, verifying patient data, adherence to the protocol of a clinical
trial in accordance with GCP/ICH guidelines, and Excel’s/sponsor’s SOPs.
 Perform on-site visits, including site qualification, initiation, monitoring and closeout
visits.
 Assist investigator meeting including preparation, liaison, presentations, problem
resolutions, and follow up.
 Ensure timely submission of protocol / consent documents for EC/IRB approval.
 Maintain all files and documentation pertaining to studies.
 Motivate investigators in order to achieve recruitment targets.
 Maintaining regular contact with study sites to ensure protocol/GCP compliance.
 Communicate progress of study and relevant information to Project Manager/Sr. CRA
and other project team members.
 Complete accurate study status reports in time.
 Ensure the correct storage of drugs and the diligent account of all drugs in accordance
with SOPs.
 Deal with CRF queries in a timely manner.
 Participate, if requested, in the preparation of and review of study documentation, e.g.
draft protocols, draft CRFs, monitoring guidelines and elements of final report.
 Ensure correct archiving of files on completion of a study.

Qualification:

 A Bachelors Degree in a medical, health, or science related area; MS degree preferred.

 Minimum of 2 years medical / science background and relevant experience; experience
of clinical trial management would be preferable.
 Knowledge of SFDA regulations and ICH/GCP guidelines.
 General knowledge of clinical/ laboratory terminology.
 Good problem solving and analytical skills.
 Computer literacy desirable.
 Strong oral and written communication skills in English.
 Must be able to travel if required.