Site Solutions Executive

3 days ago

Bengaluru, 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.
- To coordinate and support clinical trial activities related to a study or studies at a site or sites
- To support partnering and growth opportunities within the site(s) or location of the sites

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