Site Manager – Clinical Trial Operations

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🕒 July 30

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Logo of Hawthorne Health

Hawthorne Health

1 - 10 employees

Founded 2000

🏥 Healthcare

🎯 Recruiter

Healthcare • Recruitment

Hawthorne Health is a recruitment agency specializing in sourcing healthcare professionals, particularly in nursing and allied health. The company provides healthcare employment solutions, serving both clients and candidates with a commitment to quality, integrity, and affordability. Operating with a team of experienced health recruitment specialists, Hawthorne Health offers personalized services and flexible staffing solutions tailored to meet HR needs. They recruit talent from Australia and internationally, ensuring a high level of service for those seeking work and those requiring healthcare staffing.

📋 Description

• Provide operational leadership and on-site support for multiple clinical research sites across the assigned region. • Serve as the primary operational resource for assigned sites, proactively identifying and removing barriers to successful study execution. • Coordinate and execute vendor agreements and partnerships that support efficient site operations. • Support study startup activities including feasibility, site activation, staffing readiness, staff training, and sponsor/CRO coordination. • Monitor study performance metrics including enrollment, retention, protocol compliance, data quality, query resolution, and study timelines. • Identify operational challenges and implement scalable process improvements to enhance efficiency and site performance. • Partner with leadership to build and standardize operational processes, workflows, and best practices across the growing site network. • Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, sponsor protocols, and internal quality standards. • Support audit readiness and assist with sponsor, CRO, and regulatory inspections. • Monitor protocol deviations, CAPAs, and quality-related issues while partnering with site teams on corrective actions. • Promote a culture of compliance, quality, and patient safety across all assigned sites. • Build trusted relationships with Principal Investigators, Sub-Investigators, Clinical Research Coordinators, pharmacists, and site staff. • Serve as a hands-on operational partner by providing guidance, troubleshooting, and day-to-day support to assigned sites. • Support onboarding, training, and ongoing development of site personnel while promoting consistency across the network. • Navigate complex site and investigator relationships with professionalism, collaboration, and a solutions-oriented approach. • Foster strong communication and collaboration across cross-functional teams and site locations. • Build and maintain strong working relationships with Sponsors, CROs, vendors, and external partners. • Represent Hawthorne Health professionally during sponsor meetings, operational reviews, and issue escalation as needed. • Ensure timely communication and resolution of operational issues that may impact study execution or sponsor satisfaction. • Monitor operational KPIs and communicate site performance trends and opportunities to leadership. • Support achievement of enrollment goals, study milestones, and operational performance objectives. • Collaborate with leadership on new site launches, network expansion, and strategic operational initiatives.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Healthcare Administration, Business Administration, or a related field preferred. • 5+ years of clinical research experience required with recent hands-on site experience (CRC, Lead CRC, Site Manager, or similar) strongly preferred. • Strong knowledge of GCP, FDA regulations, ICH guidelines, and clinical trial operations. • Experience working with Sponsors, CROs, Principal Investigators, and clinical research sites. • Demonstrated ability to manage multiple priorities across multiple locations while maintaining strong attention to detail. • Excellent communication, organizational, relationship-building, and problem-solving skills. • Proficiency with CTMS, EDC systems, Microsoft Office, and other clinical research technology platforms. • Ability and willingness to travel regularly throughout Tennessee, Alabama, North Carolina, and South Carolina.

🏖️ Benefits

• Remote role with regular travel to assigned research sites as needed. • Ideal candidates will be located in EST or CST timezones. • Ability to travel up to 30%.

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