Medpace · 3 days ago
Study Start-Up Coordinator – Clinical Research Coordinator Experience
Medpace is a full-service clinical contract research organization (CRO) seeking a full-time Study Start-Up Coordinator to join their team. This role involves managing communications with research sites, maintaining trial documents, and ensuring compliance with regulatory requirements during the study start-up process.
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; and
Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges
Qualification
Required
A minimum of a Bachelor's degree is required (preferably in a Life Sciences field)
1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry specializing in study start-up is required
Excellent organizational and prioritization skills
Knowledge of Microsoft Office
Great attention to detail and excellent oral and written communication skills
Benefits
Flexible work environment
Competitive PTO packages, starting at 20+ days
Competitive compensation and benefits package
Company-sponsored employee appreciation events
Employee health and wellness initiatives
Community involvement with local nonprofit organizations
Discounts on local sports games, fitness gyms and attractions
Modern, ecofriendly campus with an on-site fitness center
Structured career paths with opportunities for professional growth
Discounted tuition for UC online programs
Company
Medpace
Medpace, Inc., a clinical research organization, provides clinical development services for pharmaceutical and biotechnology
Funding
Current Stage
Public CompanyTotal Funding
unknown2016-08-10IPO
2014-02-24Acquired
Recent News
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