Reg & Start Up Spec 1
Core
Proactively drives and executes start-up and maintenance activities for assigned clinical studies and sites in Chile, serving as the Single Point of Contact (SPOC) for investigative sites and internal teams.
Role type
Clinical research start-up specialist
Builds
Clinical study start-up deliverables and regulatory documentation for assigned sites
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Study start-up management, regulatory document preparation, quality control of site documents, internal system/database maintenance, project timeline planning, site performance metric review
Preferred skills
Direct contact with sponsors, contingency planning, local expertise in Chile
Technologies
Internal systems, databases, tracking tools
Responsibilities
Serve as SPOC for investigative sites and project teams; Perform site activation activities per regulations and SOPs; Prepare and review site regulatory documents for completeness and accuracy; Track and follow up on approval and execution of regulatory, ethics, and Investigator Pack documents; Provide local expertise to Site Activation Managers during project planning; Perform quality control of documents provided by sites.
Seniority
Individual Contributor, entry-level specialist
