Site Manager, Clinical Research

About the role

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.

Responsibilities

• Oversee and manage the daily operations of an assigned clinical research site while ensuring efficient workflows, operational excellence, and achievement of organizational objectives.
• 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.
• Supervise, coach, train, and support Clinical Research Coordinators, Raters, Recruitment Specialists, and other site personnel while fostering accountability, collaboration, and continuous improvement.
• Work closely with recruitment staff to achieve enrollment goals, improve participant retention, and provide exceptional participant experience throughout each study.
• Clock in and coordinate schedules for Principal Investigators, Sub-Investigators, Coordinators, Raters, participants, and other study personnel to maximize site productivity and operational efficiency.
• 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.
• Ensure accurate, timely, and complete maintenance of regulatory binders, Trial Master Files (TMFs), source documentation, essential documents, and study records.
• Identify opportunities to improve workflows, SOPs, scheduling, communication, and operational efficiency while maintaining high standards of quality and compliance.
• 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.
• Support participants throughout the research process by addressing questions, assisting with scheduling, promoting retention, and ensuring a positive research experience.
• Serve as the primary operational contact during routine monitoring visits while maintaining strong working relationships with sponsors, CROs, and study monitors.
• Aid in interviewing, onboarding, training, mentoring, scheduling, and performance management of site personnel while promoting a culture of professional growth.
• Monitor enrollment, participant retention, protocol compliance, visit completion, scheduling efficiency, staffing productivity, and operational performance to ensure site success.
• Support organizational growth by assisting with feasibility assessments, sponsor questionnaires, and study startup activities as requested.

Requirements

• 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
• Experience with 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