Clinical Research Site Lead
Reports To: Director, Site Management
Department: Site Operations
Employment Type: Full-Time, On-Site
Position Summary
The Clinical Research Site Lead is a hands-on leadership role responsible for the daily operations of a clinical research site. This individual serves as both a study coordinator and a line manager, ensuring high-quality study conduct, efficient participant logistics, and operational excellence. The Site Lead is the face of the site—representing it in cross-functional communications, driving team performance, and continuously identifying ways to improve processes and outcomes. This role offers a strong opportunity for growth into broader leadership within the clinical site network.
Key Responsibilities
People Management & Site Leadership
- Directly manage site-based staff, including Clinical Research Coordinators and support personnel.
- Track and report staff attendance, punctuality, and performance.
- Oversight of clinic diary management and site specific staff resourcing to maximize site productivity
- Conduct regular coaching, performance reviews, and team development.
- Foster a culture of accountability, collaboration, and continuous improvement.
Participant Logistics & Experience
- Oversee participant scheduling, visit flow, and onsite experience to ensure smooth, timely, and high-quality visits.
- Troubleshoot logistical challenges and implement solutions to improve participant satisfaction and retention.
- Ensure the site is always visit-ready and aligned with enrollment and retention goals.
Study Conduct & Quality Oversight
- Lead the execution of Phase II–IV investigational product studies as a hands-on coordinator.
- Ensure protocol adherence, data integrity, and regulatory compliance.
- Maintain audit readiness and support inspections as needed.
Technology & Systems Proficiency
- Ensure functionality and maintenance of all IT equipment (computers, tablets, printers, etc.).
- Oversee and train staff on the use of clinical systems including:
- AI-enabled tools
- Electronic consent platforms
- Electronic source and regulatory filing systems
- CTMS platforms (e.g., CRIO, Hubspot)
- Serve as the liaison with IT support for troubleshooting and upgrades.
Operational Excellence & Site Representation
- Act as the primary point of contact for the site, representing it in internal and external communications.
- Monitor and report on site productivity, efficiency, and performance metrics.
- Identify and implement process improvements to enhance operational efficiency and participant experience.
- Lead site efforts both personally and with the team, in procuring local services, including vendors where required
Qualifications
- Bachelor’s degree in a health-related field or equivalent experience.
- Minimum of 5 years of experience in clinical research, specifically as a Study Coordinator for Phase II–IV investigational product studies.
- At least 1–2 years of management or supervisory experience in a clinical or healthcare setting.
- Strong leadership, organizational skills, and communication skills.
- Proficiency in clinical trial software and Microsoft Office Suite.
- Demonstrated ability to manage participant logistics and lead site operations.
- Ability to travel between sites as needed.
Preferred Skills
- Experience with CRIO, Hubspot, or similar CTMS platforms.
- Familiarity with AI tools, eSource, eConsent, and electronic regulatory systems.
- Proven ability to lead teams, manage logistics, and drive operational excellence.
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