Experienced Study Start-Up Coordinator
Core
Coordinate regulatory submissions and site activation for clinical trials to ensure timely patient screening and trial initiation.
Role type
Study Start-Up Coordinator (Clinical Operations)
Builds
Clinical trial start-up processes and regulatory compliance for biotechnology, pharmaceutical, and medical device clients.
Domain
Clinical Research / Clinical Trials
Deliverable
client delivery
Required skills
Regulatory submission management, site activation coordination, TMF quality review, timeline management, compliance guidance, regulatory research
Preferred skills
Life Sciences degree, pharmaceutical industry experience
Technologies
Microsoft Office
Responsibilities
Communicate with research sites to collect essential documents for patient screening; Maintain and perform quality review of trial documents in the TMF; Assemble regulatory start-up submissions for IRBs; Maintain study start-up timelines; Provide compliance guidance to internal and external teams; Review regulations to develop solutions for regulatory issues.
