Trial Documentation Associate I
Core
Regulatory document specialist supporting clinical trial operations from study start-up through close-out, ensuring documentation compliance and inspection readiness.
Role type
Trial Documentation Associate I (Clinical Trials Administration)
Builds
Regulatory files and electronic Trial Master Files (eTMF) for clinical studies
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Regulatory document management, eTMF setup and maintenance, protocol activation, CTMS system usage, compliance with ICH GCP guidelines
Preferred skills
TMF/eTMF proficiency, ICH/GCP guidelines knowledge, clinical trial regulatory document flow management, study start-up and site management experience
Responsibilities
Collect, review, and maintain essential regulatory documents; Activate new and amended protocols at an institutional level; Track and update documentation, study status, and key milestones within CTMS and eTMF; Communicate with study, monitoring, sponsor, and site teams; Monitor case report forms for lowest risk studies; Ensure compliance with study procedures and conventions
Seniority
Individual Contributor, Entry to Mid-level
