About the job
Position at Premier Research
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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