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Medpace · 2 weeks ago

Study Start-Up Coordinator – Clinical Research Coordinator Experience

Irving, TX

Full-time

Onsite

Entry, Mid Level

1+ years exp

Medpace is a full-service clinical contract research organization that provides clinical development services. The Study Start-Up Coordinator will play a key role in the clinical trial management and study start-up process, collaborating with research sites to ensure compliance and maintain timelines for study start-up.

BiotechnologyPharmaceutical

Responsibilities

Communicate with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial

Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF)

Collect, review, organize, and assemble regulatory start-up submissions (including submissions to Institutional Review Boards (IRB)

Maintain timelines for study start-up through both internal and external collaboration

Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements

Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges

Qualification

Clinical trial managementRegulatory submissionsStudy start-up experienceLife Sciences degreeMicrosoft Office knowledgeOrganization skillsCommunication skills