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Key Responsibilities:
- Provide operational oversight and support for multiple clinical research sites within the network.
- Monitor site performance metrics including enrollment, retention, protocol compliance.
- Ensure consistent implementation of SOPs, operational workflows, and best practices across all assigned sites.
Clinical & Regulatory Compliance:
- Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
- Support audit readiness and assist with sponsor, CRO, and regulatory inspections/audits.
- Monitor protocol deviations, CAPAs, and quality-related issues and collaborate with site teams on corrective actions.
Sponsor & CRO Relationship Management:
- Build and maintain strong working relationships with Sponsors, CROs, and external partners.
- Ensure timely communication and resolution of operational issues impacting study execution or sponsor satisfaction.
Hawthorne Health
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.