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Clinical Research Manager
1 week ago
About the Role
The Site Activation Specialist will execute feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level. This includes preparing and managing site documentation, reviewing and negotiating site documents and contracts with sites and sponsors, maintaining, reviewing, and reporting on site performance metrics, serving as the primary point of contact for investigative sites, tracking completion of appropriate documents for sites, ensuring contracts are fully executed, and establishing project timelines.
Key Responsibilities
- Serve as 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.
- 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.
