Clinical Research Site Lead

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.