Care Access · 1 month ago
Director, Clinical Research Operations
Care Access is dedicated to improving health services and clinical research accessibility globally. The Director of Clinical Research Operations will lead clinical staff across various research sites, ensuring high-quality study execution and compliance with regulatory standards.
Clinical TrialsHealth Care
Responsibilities
Lead clinical operations across physical sites, mobile units, and traveling clinical teams
Ensure high-quality protocol execution, participant safety, and adherence to GCP and FDA regulations
Oversee clinical workflows at sites and mobile deployments, resolving issues impacting quality, recruitment, or compliance
Manage, develop, and evaluate all clinical research staff (CRCs, nurses, mobile clinicians, and traveling staff)
Implement training, competency standards, and performance expectations for all clinical staff
Provide input into staffing budgets, resource planning, and clinical support models
Monitor enrollment, data quality, documentation practices, and clinical performance metrics
Partner with regulatory, medical, data, participant experience, and site operations teams to support successful trial delivery
Drive continuous improvement in clinical quality, consistency, and operational efficiency
Qualification
Required
Strong knowledge of ICH-GCP, FDA regulations, and clinical trial execution
Excellent leadership, communication, and performance-management skills
Ability to thrive in dynamic environments and manage diverse clinical teams
Bachelor's degree in a health-related field required; advanced degree preferred
12+ years of clinical research operations experience, including leadership of multisite or dispersed clinical teams
Experience overseeing CRCs, nurses, mobile clinicians, or traveling clinical staff
Preferred
Advanced degree preferred
Benefits
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Company
Care Access
Care Access helps people learn more about their health and participate in clinical research to help find new medicines and cures.
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Biomedical Advanced Research and Development Authority (BARDA)
2024-08-26Grant
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