Clinical Research Coordinator 2, Department of Surgery

About the role

The Clinical Research Coordinator 2 (CRC2) is a specialized researcher working with the Principal Investigator (PI), Co-Investigator(s) and other study personnel. Under limited direction of departmental leadership, the CRC2 supports and provides guidance on the administration of the compliance, financial and other related aspects of the clinical study.

Responsibilities

• Research Conduct/Study Management:
  • Manages multiple moderately complex clinical trials that may include national level and multi-institutional pharmaceutical.
    • Recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.
      • Conducts all sponsor-related visits and acts as a liaison between sponsor and PI.
        • Reviews and meets regularly with PI to review study portfolio.
          • Participates in study start-up activities.
            • Works with the lab team to process and collect samples for internal processing.
              • Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.
                • Collections, processes, ships, and stores specimens to appropriate laboratory according to established aseptic techniques.
                  • Identifies adverse events and protocol deviations or violations, reports findings to PI, sponsor, and IRB under general direction of clinical research manager.
                    • Organizes and actively participates in site visits from sponsors and other relevant study meetings.
                      • Maintains a safe research environment and ensures compliance with governmental and University policies, procedures, and regulations.