HealthCare Recruiters International ยท 2 days ago
Director, Clinical Study Quality (GCP)
St. Petersburg, FL
Contract
Hybrid
Director/ExecutiveHealthCare Recruiters International is seeking a Director of Clinical Study Quality (GCP) to provide oversight support for a Class II medical device clinical study. The role involves acting as an independent clinical advisor, supplementing internal expertise with clinical trial oversight experience, and ensuring adherence to GCP and regulatory requirements.
Health CareHuman ResourcesMedical
Hiring Manager
Willie Frederick
Responsibilities
Review key CRO outputs (e.g., monitoring reports, issue logs, deviation summaries)
Provide independent assessment of whether CRO activities align with:
The approved protocol
GCP expectations
Sponsor oversight requirements
Identify gaps, risks, or trends requiring Sponsor attention
Advise Quality & Regulatory on escalation or corrective actions
Review adverse event summaries and safety trends
Provide clinical perspective on emerging risks
Support Sponsor discussions related to subject protection and safety management
Advise, but not decide, on regulatory safety actions
Advise on adequacy of the CRO monitoring strategy
Perform Sponsor-side monitoring visits, when requested
Preference for local presence near the investigator site to:
Improve efficiency
Reduce travel burden
Align with best practice
Provide written monitoring feedback to Sponsor leadership
Support Sponsor oversight of the Trial Master File (TMF)
Spot-check completeness of Sponsor-relevant records
Assist with audit, inspection, or diligence preparation if required
Serve as a clinical and GCP subject-matter expert
Provide guidance, not ownership
Support Sponsor decision-making while final authority remains internal
Qualification
Required
Demonstrated experience in clinical trial oversight
Demonstrated experience in CRO oversight or monitoring
Demonstrated experience in FDA- or GCP-regulated studies
Strong working knowledge of CH-GCP Sponsor oversight expectations
Strong working knowledge of FDA clinical investigation requirements for NSR device studies
Ability to operate independently and provide clear, practical guidance
Company
HealthCare Recruiters International
HealthCare Recruiters International is a staffing and recruiting company specializing in medical staffing solutions.
Founded in 1986
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Jon Guidi
President/CEO
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