Job description
ABOUT THIS ROLEIn Parexel FSP we are looking for a Site Activation Partner based in the UK.Position Purpose:The Site Activation Partner 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.Primary Responsibilities:Clinical Trial Site ActivationInitiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.Register investigator sites and Client stakeholders in Client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status.Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable.
Responsibilities & skills
Education
Post site activation, initiate and coordinate activities and essential documents management with the investigators 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.
Experience
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Parexel
At Parexel, we work every day to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do. We’re not just the people with brains, we’re the people with heart.Disrupting the Bench to Bedside PhilosophyPrecision medicine brings insights from the bench to bedside, but we need to share information from the bedside back to the bench to innovate drug development.Learn more about expanding this philosophy from industry leaders
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