Site Solution Executive

2 days ago


Remote, India Premier Research Full time

To coordinate and facilitate all Clinical trial activities at site ensuring compliance with protocol, applicable GCP guidelines and local regulations ;
- To support Principal Investigator (PI) and site study team assuring that the clinical trial(s) being conducted meet all the criteria set by the sponsors and regulators - To fulfil the duties and responsibilities stated above, the SSE will perform the following functions: ― Performs timely data entry of the Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the PI/ Investigator ― Maintaining clinical trial-related documents at site including Trial Master File. ― Preparing for, facilitating and assisting at site initiation, monitoring and close-out visits, protocol-prescribed and other necessary patient-visits, QA visits, sponsor visits and Inspections. ― Reporting site-performance metrics at pre-determined frequency. ― Coordinating submissions to ethics committee of protocol, adverse events and periodic study reports for review and ensuring that all documentation to and from ethics committee is appropriately maintained.



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