Study Start-Up Coordinator (CRC Experience)
Core
Coordinate study start-up activities by communicating with research sites to collect essential documents and assemble regulatory submissions for clinical trials.
Role type
Study Start-Up Coordinator (Clinical Research)
Builds
Regulatory submissions and site activation packages for clinical trials
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Regulatory document collection, Trial Master File (TMF) management, IRB submission assembly, timeline management, compliance guidance, regulatory research
Preferred skills
Life Sciences background, study start-up experience
Technologies
Microsoft Office
Responsibilities
Communicate with research sites to collect essential documents; Maintain and perform quality review of trial documents in TMF; Collect, review, organize, and assemble regulatory start-up submissions; Maintain timelines for study start-up; Provide compliance guidance to team members; Review regulations to develop proactive solutions
Seniority
Junior to Mid-level, hands-on IC
