Clinical Research Supervisor

University of Colorado Anschutz

Department: Cancer Center

Working Title: Clinical Research Supervisor

Position #: 00693007 – Requisition #: 40375

Job Summary:

As an important member of the research team, the Clinical Research Supervisor will report to the team manager This position works with Phase I-IV industry-sponsored, co-operative group and or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. It is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs. This position is responsible for coordinating study subject appointments throughout the study as well as scheduling, coordinating, and preparing for monitoring visits and audits. The incumbent is responsible for data entry and resolution, study subject advocacy; and possible management of studies at the local level. 

Key Responsibilities:

Staff Management 40%:

• Under Manager’s guidance, arranges orientation and provides training, supervision and leadership to the clinical research staff.

• Assigns patient and trials to staff with guidance from Clinical Research Manager.

• Supervises team vacation, out of office coverage, time management of direct reports.

• Plans and directs investigator and coordinator meetings including but not limited to team meetings, initial orientations, study audits, and closeout visits. 

• Under Manager’s guidance, makes recommendations regarding clinical research personnel issues, including hiring decisions, performance evaluations, counseling, and disciplinary actions.

Administrative/Quality Control 40%:

• Participates in reviewing and tracking deviation trends leading to review of processes. 

• Performs quality assurance checks by reviewing patient shadow charts, monitor letters, audit results, OnCore entry, data entry.

• Performs quality assurance checks by reviewing patient shadow charts, monitor letters, audit results, OnCore entry, data entry.

• Supervisor Meetings – Attend and bring items from team to meeting and provides updates back to team.

Patient Care 20%:

• Maintain 2-5 study participants at any given time and management of day-to-day issues such as scheduling conflicts, infusion issues, enrollment packet review under the direction of the CRM if problems escalate.

Work Location:

Hybrid – this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings after 6 months with supervisory approval.

Why Join Us:

The University of Colorado Ca