Posted: 4h ago
The role
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. Powered by JazzHR