This role focuses on clinical research site leadership, operational oversight, regulatory compliance, participant recruitment, team development, and business growth.
- Clinical Research Operations Leadership: Oversee and manage daily clinical research operations across the Stuart location and other designated research sites while ensuring adherence to approved workflows, protocols, and organizational objectives.
- Clinical Trial Execution: Lead the successful execution of clinical trials from study startup through closeout while ensuring compliance with ICH-GCP guidelines, FDA regulations, sponsor requirements, and internal procedures.
- Research Team Leadership: Recruit, train, develop, supervise, and evaluate research coordinators, raters, recruitment personnel, and other site staff while fostering a culture of accountability, collaboration, and continuous improvement.
- Participant Recruitment and Retention: Develop and implement strategies to increase participant recruitment, enrollment, retention, and overall study productivity while maintaining exceptional participant experiences.
- Scheduling and Productivity Management: Coordinate and optimize schedules for Principal Investigators, Sub-Investigators, Coordinators, Raters, and other study personnel to maximize operational efficiency and study performance.
- Quality and Regulatory Compliance: Ensure compliance with all applicable regulations, protocols, sponsor requirements, and company policies while maintaining inspection readiness and supporting audits, monitoring visits, and quality assurance activities.
- Study Documentation Oversight: Ensure timely collection, maintenance, reconciliation, and archiving of regulatory documents, study records, and Trial Master File (TMF) documentation.
- Operational Process Improvement: Continuously evaluate and improve site workflows, SOPs, systems, and operational processes to enhance efficiency, quality, compliance, and participant outcomes.
- Scientific and Clinical Support: Provide operational and clinical development input to support the safe, efficient, and successful execution of assigned studies and research programs.
- Monitoring and Sponsor Engagement: Serve as a primary site leader during sponsor visits, monitoring visits, audits, and inspections while maintaining strong sponsor relationships and ensuring successful site performance.
- Clinical Research Support: Maintain the ability to perform coordinator-level responsibilities as needed, including blood draws, ECGs, specimen processing, sample shipment, participant visits, and other protocol-related activities.
- 24-Hour Study Support: Participate in study-related emergency coverage and provide support to study participants and caregivers when urgent protocol-related matters arise.
- Participant Care and Retention Support: Support participants throughout their research journey, including assisting with retention efforts, participant engagement, hospital visits, and after-hours communication when necessary.
- Business Development and Growth: Assist in expanding research opportunities through study acquisition efforts, investigator recruitment, strategic partnerships, and participation in business development initiatives.
- Talent Acquisition and Workforce Development: Support recruitment, interviewing, workforce planning, budgeting, and onboarding efforts for research staff, investigators, raters, and other key personnel.
- Performance Metrics and Site Growth: Monitor site performance metrics, enrollment goals, productivity benchmarks, and financial objectives while implementing strategies to drive continued growth and operational success.
- Industry Representation: Represent the organization at sponsor meetings, industry conferences, networking events, and other professional engagements to support organizational visibility and growth.
- Strategic Planning: Contribute to long-term planning, operational strategy, and future business opportunities that support organizational growth and sustainability.
- Other Duties as Assigned
What You'll Bring
- Bachelor's degree in Healthcare Administration, Life Sciences, Nursing, Business Administration, or related field preferred
- 5+ years of clinical research experience with progressive leadership responsibilities
- Previous experience managing clinical research operations and site personnel
- Strong understanding of ICH-GCP guidelines, FDA regulations, IRB requirements, and clinical trial processes
- Experience leading study startup, enrollment, monitoring, and closeout activities
- Strong leadership, communication, organizational, and problem-solving skills
- Ability to manage multiple studies, priorities, and stakeholders simultaneously
- Experience with participant recruitment and retention strategies
- Experience with SOP development, quality management, and process improvement initiatives
- Ability to perform clinical research procedures such as phlebotomy, ECGs, specimen processing, and participant visits as needed
- Experience in psychiatric, CNS, or inpatient clinical research preferred
- Business development and sponsor relationship experience preferred
What We Offer
- Comprehensive Medical Plans
- Dental Insurance
- Vision Insurance
- Long-Term Disability
- Employer-paid Life Insurance
- Voluntary Benefits
- Employee Assistance Program (EAP)
- Paid Vacation Time
- Paid Sick Time
- Paid Federal Holidays
