Site Activation Specialist
3 weeks ago
Job Overview
Under moderate supervision, this role executes feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level. Tasks include preparing and managing site documentation, reviewing and negotiating site documents and contracts with sites and sponsors, and maintaining, reviewing, and reporting on site performance metrics. The incumbent serves as the primary point of contact for investigative sites, tracks completion of appropriate documents for sites, ensures contracts are fully executed, and establishes project timelines.
Essential Functions
- With moderate oversight and supervision, this role is a Single Point of Contact (SPOC) to perform feasibility, site activation, and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs, and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Prepare site documents, reviewing for completeness and accuracy.
- Inform team members of completion of regulatory contractual, and other documents for individual sites.
- Distribute completed documents to sites and internal project team members.
- Update and maintain internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project-specific information.
- Review, track, and follow up on the progress, approval, and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents.
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