Clinical Research Associate

Role & responsibilities

To overall coordinate the activities of CPU at ARL.

To inform to the volunteer coordinator (from outside source) about the details of the study and confirm the participation of the required number of volunteers as per the study protocol. Preparation of trial master file, source documents, labels of the study.

To monitor the activities like dosing, sample collection and sample processing, during study activities.

To review synchronization of clock.

To co-ordinate outside laboratory.

To co-ordinate with canteen department related to study activities and its menu.

To review temperature and humidity records of sample collection area, sample processing area, housing area before initiation of the relevant activities. To maintain volunteer databank, age proof records.

To do all IP related activities like IMP Receipt, IMP acceptance, IMP dispensing and reconciliation etc.

To record and review the study documents.

To dose the subjects and monitor the posture restriction.

To report all study related deviations to the Principal Investigator.

To work as a authorized trained person in pharmacy activities.

Any other responsibilities assigned by the Principal Investigator.