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 Comfortable training in the West Palm Beach office as needed 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 Equal Opportunity Employer We are an equal opportunity employer and comply with all applicable federal, state of Florida, and local employment laws. 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