Site Solutions Executive

1 week ago

Remote, India Premier Research Full time

**Job Description**:

- 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 fulfill 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.
- ― Assisting in scheduling patient investigations and assessments per instructions of Principal Investigator- ― Assuring that all work at site prescribed by the approved protocol, the contract and the EC is performed in a timely and comprehensive manner
- ― Organizing and coordinating laboratory sample pick-ups and reporting
- ― Transcribing source documents if required under the supervision of the PI or designated person and ensuring that they are reviewed and signed off by the responsible person.
- ― Assisting in timely resolution of data queries- ― Maintaining regular contact with site monitor regarding patient enrolment, visit scheduling, dosing/dispensing
- ― Facilitating cordial and timely communication between investigator and sponsor/CRO
- ― Supporting patient-awareness, training or other events at site or in the neighborhood
- ― Supporting data collection activity at site including but not limited to feasibilities, epidemiological data
- ― Responsible to complete Cytestream within the stipulated timeline
- ― Support in the execution of the CTA
- ― To create the database of potential patients that can be enrolled into the study as per the protocol
- ― To identify any challenges and find out mitigation plan in advance with the support of LM, TSM & PI
- ― Responsible to complete all mandated training and ongoing training modules and SOPs
- ― Responsible for notifyingSponsor / CRO representatives of external audits/ inspections bythe sponsor and regulatory authorities respectively.
- ― Collaborates with PI to respond to any audit findings and implement approved recommendations.
- ― Escalate systemic non-compliance and/or misconduct to his /her manager for appropriate follow-up.
- ― Shall direct all feasibilities coming to the site to feasibility team at Premier.

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