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.