Clinical Research Associate

Roles and Responsibilities
To provide assistance, where directed by the Project Manager, in specific tasks relating to the preparation of the project (e.g. preparation of protocols; icf, preparation of planning documents).
To maintain awareness of local regulatory requirements, and to conduct studies in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines.
To make regular contact with investigators or other site staff members during the course of studies, to ensure everything is proceeding to agreed protocols and time schedules, and the data is recorded accurately.
To review all data produced from each study and resolve any data queries/protocol deviations identified.
To provide a report, as required, of status of each of the studies for which he/she is responsible, and make any necessary recommendations for contingency planning.
To maintain effective communication with other members of the clinical team and management.
Requirements
B.Pharm/M.Pharm/M.Sc (Life sciences) with 1-2 Yrs experience as CRA in a reputed CRO dealing with Clinical Trials.
Training in GCP.
Relevant exp. in conducting multi-centric Clinical Trials.
Knowledge of processing & reporting AE/SAE events