This role focuses on day-to-day site operations, clinical trial execution, regulatory compliance, participant recruitment, staff leadership, and ensuring the overall success of one assigned clinical research site.
- Site Operations Management: Oversee and manage the daily operations of an assigned clinical research site while ensuring efficient workflows, operational excellence, and achievement of organizational objectives.
- Clinical Trial Execution: Ensure the successful execution of clinical trials from study startup through closeout while maintaining compliance with ICH-GCP guidelines, FDA regulations, sponsor requirements, and internal SOPs.
- Research Team Leadership: Supervise, coach, train, and support Clinical Research Coordinators, Raters, Recruitment Specialists, and other site personnel while fostering accountability, collaboration, and continuous improvement.
- Participant Recruitment and Retention: Work closely with recruitment staff to achieve enrollment goals, improve participant retention, and provide exceptional participant experience throughout each study.
- Scheduling and Resource Management: Coordinate schedules for Principal Investigators, Sub-Investigators, Coordinators, Raters, participants, and other study personnel to maximize site productivity and operational efficiency.
- Quality and Regulatory Compliance: Maintain inspection readiness by ensuring compliance with study protocols, sponsor requirements, FDA regulations, IRB requirements, and company policies while supporting monitoring visits, audits, and quality initiatives.
- Study Documentation Oversight: Ensure accurate, timely, and complete maintenance of regulatory binders, Trial Master Files (TMFs), source documentation, essential documents, and study records.
- Operational Process Improvement: Identify opportunities to improve workflows, SOPs, scheduling, communication, and operational efficiency while maintaining high standards of quality and compliance.
- Clinical Research Support: Maintain the ability to perform Clinical Research Coordinator responsibilities as needed, including participant visits, blood draws, ECGs, specimen processing, sample shipment, and protocol-required procedures.
- Participant Care: Support participants throughout the research process by addressing questions, assisting with scheduling, promoting retention, and ensuring a positive research experience.
- Sponsor and Monitor Collaboration: Serve as the primary operational contact during routine monitoring visits while maintaining strong working relationships with sponsors, CROs, and study monitors.
- Staff Development: Assist with interviewing, onboarding, training, mentoring, scheduling, and performance management of site personnel while promoting a culture of professional growth.
- Site Performance Management: Monitor enrollment, participant retention, protocol compliance, visit completion, scheduling efficiency, staffing productivity, and operational performance to ensure site success.
- Business Development Support: Support organizational growth by assisting with feasibility assessments, sponsor questionnaires, and study startup activities as requested.
- Other Duties as Assigned
What You'll Bring
- Bachelor's degree in healthcare administration, Life Sciences, Nursing, Business Administration, or a related field preferred
- 3+ years of clinical research experience with increasing operational responsibilities
- Previous experience supervising or leading clinical research staff preferred.
- Strong understanding of ICH-GCP guidelines, FDA regulations, IRB requirements, and clinical trial operations
- Experience managing study startups, enrollment, participant visits, monitoring visits, and study closeout.
- Strong organizational, leadership, communication, and critical thinking skills
- Ability to manage multiple studies, competing priorities, and deadlines in a demanding environment.
- Experience with participant recruitment and retention strategies
- Experience with SOP implementation, quality management, and operational process improvement
- Ability to perform clinical research procedures including phlebotomy, ECGs, specimen processing, and participant visits as needed.
- Experience in psychiatrics, CNS, or inpatient clinical research preferred.
- Strong interpersonal skills with the ability to build collaborative relationships with physicians, sponsors, CROs, participants, and internal teams.
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
