Study Start-Up Coordinator – Clinical Research Coordinator Experience
Core
Coordinate regulatory submissions and site activation for clinical trials by managing documentation and timelines with research sites.
Role type
Regulatory Submissions Coordinator (Clinical Research)
Builds
Regulatory start-up submissions and Trial Master Files for clinical trials
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Regulatory submission management, Trial Master File (TMF) maintenance, site communication, timeline management, compliance knowledge, Microsoft Office
Preferred skills
Life Sciences degree, study start-up experience, pharmaceutical industry experience
Responsibilities
Communicate with research sites to collect essential documents for patient screening; Maintain and perform quality review of trial documents within the Trial Master File; Collect, review, organize, and assemble regulatory start-up submissions including IRB submissions; Maintain timelines for study start-up through internal and external collaboration; Provide advice and guidance to ensure compliance with regulations; Review regulations to develop proactive solutions to regulatory issues.
