Experienced Study Start-Up Research Coordinator
Core
Coordinate regulatory submissions and site activation for clinical trials by managing documentation, timelines, and communications with research sites.
Role type
Study Start-Up Research Coordinator
Builds
Regulatory submissions to Institutional Review Boards (IRBs) and Trial Master Files (TMF) for clinical trials
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
IRB submission management, Informed Consent Form development, regulatory compliance knowledge, document organization, timeline management, site communication
Preferred skills
Life Sciences degree background, Microsoft Office proficiency
Technologies
Microsoft Office
Responsibilities
Communicate with research sites to collect essential trial documents; Maintain and perform quality review of trial documents within the Trial Master File; Collect, review, organize, and assemble regulatory start-up 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.
