RSU Specialist I, FSP Sponsor Dedicated
Core
Proactively drives and executes start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country.
Role type
Regulatory & Start Up Specialist I
Builds
Regulatory documents, site activation packages, and project timelines for clinical studies
Domain
Clinical research / Life sciences
Required skills
Study start up management, regulatory document preparation, internal system maintenance, project planning, quality control of site documents, site performance metric review
Preferred skills
Direct contact with sponsors, contingency planning, local expertise for project timeline planning
Technologies
Internal systems, databases, tracking tools
Responsibilities
Serve as Single Point of Contact (SPOC) for investigative sites, SAM, and project management teams; Perform start up and site activation activities according to regulations and SOPs; Prepare and review site regulatory documents for completeness and accuracy; Ensure accurate completion and maintenance of internal systems and databases; Review and provide feedback on site performance metrics; Review, establish, and agree on project planning and timelines; Track and follow up on the approval and execution of regulatory, ethics, and Investigator Pack documents; Provide local expertise to SAMs and project team during project timeline planning; Perform quality control of documents provided by sites.
Seniority
Individual Contributor, entry-level
