Study Start-Up Coordinator- PharmD
Core
Coordinate regulatory submissions and site activation for clinical trials by communicating with research sites and managing trial documentation.
Role type
Entry-level clinical operations coordinator (study start-up)
Builds
Clinical trial infrastructure and regulatory compliance for biotechnology and pharmaceutical clients
Domain
Clinical research / Regulatory affairs
Deliverable
client delivery
Required skills
Regulatory submission management, Trial Master File (TMF) maintenance, IRB submission coordination, timeline management, regulatory guidance review
Preferred skills
Office environment experience, Microsoft Office proficiency
Technologies
Microsoft Office
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; Review pertinent regulations and guidance to develop proactive solutions to regulatory issues.
Seniority
Entry-level, hands-on IC
