Site Activation Partner I - FSP
Core
Support clinical research studies from site start-up through close-out, ensuring accurate and compliant site activation and ongoing operations.
Role type
Clinical Site Activation Specialist
Builds
Clinical trial site readiness and regulatory documentation packages
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Clinical trial site activation, Regulatory and ethics documentation management, Investigator Initiation Package (IIP) preparation, Clinical trial systems proficiency (CTMS, eTMF, eISF), GCP compliance, Cross-functional collaboration
Preferred skills
Pharmaceutical or CRO experience, US/Canada clinical trial knowledge, Life Sciences degree
Technologies
CTMS, eTMF, eISF, Document portals, Investigator platforms
Responsibilities
Lead site activation activities and compile Investigator Initiation Packages, Coordinate with investigator sites to confirm readiness and resolve issues, Prepare and track regulatory/ethics submissions (IRB, FDA 1572), Maintain accurate trial records in clinical systems, Support study conduct post-activation with documentation updates, Provide guidance to site personnel on GCP and operational requirements
Seniority
Mid-level, hands-on IC
