Parexel FSP is looking for Site Activation Partners to join our team. Candidates must have at least 2 years of start-up experience and experience with US/CAN. This is a 7-month temporary assignment with the potential to transition into a full-time role.
Job Overview:
The Site Activation Partner I (SAP I) is responsible for leading or supporting operational activities from start up to close out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client standards. Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.
Key Accountabilities:
Clinical Trial Site Activation:
Prepare, validate and submit regulatory documents such as completed IIP, Institutional Review Board (IRB) approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
Clinical Trials Conduct:
Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, ethics committee annual approvals and other activities required during study conduct
Communication:
Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals
Clinical Trial Site Support:
As needed, perform, awareness session with site personnel on client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and client standards
Subject Matter Expert (SME):
Compliance with Parexel standards:
Skills:
Knowledge and Experience:
Education:
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