Clinical Research Site Manager

The Role

The Site Manager performs clinical research activities as a Clinical Research Coordinator while also serving as Manager of the site operations. The Site Manager owns meeting or exceeding financial targets, KPIs, and patient enrollment, as well as champions screening, patient retention, and partnering with other Headlands centralized departments or sites.

Position Type: Full-time

Location: Onsite in Riverside, CA

Responsibilities:

• Strategic and Operational Management
  • Evaluates overall performance of the Site and recommends and implements processes and plans for improvement.
  • Responsible for maintaining a site calendar to ensure adequate enrollment for studies and coordination of employee PTO.
• Staff Development and Management
  • 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
• Quality Assurance & Compliance
  • 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
• Clinical Research Coordination
  • In addition to assuming management responsibilities as a Site Manager, this individual performs the duties of a Clinical Research Coordinator
  • Protects the rights, safety, and welfare of human subjects, follows Good Clinical Practice, and works cooperatively with others
  • Monitors study activities to ensure compliance with study protocols, with site policies, and with applicable federal, state, and local regulations
  • Oversee 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
• Documentation and Reporting
  • 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
• Performs other duties as assigned, including duties routinely performed by the Company’s Research Assistants

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
• 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.

Preferred Qualifications:

• Bachelor’s degree
• Capability to perform phlebotomy procedures
• CCRC or CCRP certified