Clinical Research Site Manager

Responsibilities

• Evaluates overall performance of the Site and recommends and implements processes and plans for improvement.
• Maintains a site calendar to ensure adequate enrollment for studies and coordination of employee PTO.
• Fosters a culture of excellence, teamwork, and innovation among site staff.
• Hires, trains, and mentors site staff, including Clinical Research Coordinators, Research Assistants, Administrative Assistants, Registered Nurses, support personnel, etc.
• Partners with Human Resources and Management when hiring new employees for the site by reviewing candidate credentials, conducting interviews, and giving input about potential new hires.
• Supervises performance of other Clinical Research Coordinators, Research Assistants, and support staff at the Site.
• Maintains up-to-date knowledge of all relevant regulatory guidelines and requirements.
• Ensures the site’s compliance with FDA, ICH, and local regulatory agency regulations.
• Performs clinical research activities as a Clinical Research Coordinator.
• Protects the rights, safety, and welfare of human subjects, follows Good Clinical Practice, and works cooperatively with others.
• Makes sure study activities comply with study protocols, site policies, and applicable federal, state, and local regulations.
• Oversees the planning, initiation, and execution of clinical trials at the site.
• Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms.
• Manages and optimizes patient recruitment and retention efforts.
• Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other healthcare professionals.
• Addresses any patient concerns or issues promptly and professionally.
• Documents findings and events in the CTMS platform and in other binders and platforms as directed.
• Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.

Requirements

• 5+ years of experience as a delegated Clinical Research Coordinator on multiple phase 2-4 clinical research trials, simultaneously.
• Proficiency in FDA regulations governing clinical trials.
• Strong supervisory skills to lead research staff effectively.
• The ability to collect and manage research data accurately.
• Familiarity with documentation review processes in clinical research.
• Knowledge of medical terminology relevant to clinical trials management.
• IATA (dangerous goods handling).
• GCP (Good Clinical Practice).
• Strong communication skills with all members of the team.