Clinical Sciences Program Director

University of Colorado Anschutz Medical Campus

Department: Ophthalmology

Job Title: Clinical Sciences Program Director

Position #00842864 – Requisition # 38393

Job Summary:

The Department of Ophthalmology seeks a full-time Clinical Research Program Director.  The position is responsible for the management of all clinical research operations through the department, including: pharmaceutical-based trials, investigator-initiated research and trials, bio-banking, and internal clinical research.  This position will play a key role in developing and executing broad research goals with department leadership, establishing best-in-class operational procedures, growing patient and study enrollment, and mapping out the strategic priorities for clinical research. .  Main components of the job include 1) management of all departmental human-subject research, and the study coordinator teams, 2) administration of the internal and external regulatory processes, 3) support of finance-related activities in partnership with the department finance team, and 4) functioning as a trainer for study coordinators and backup coordinator as needed

Tasks including project development such as editing protocols, writing consent forms and subject materials, and interpretation of protocols for the preparation of source documents, analysis of results and contribution to publications.  Regulatory tasks include local and central IRB submissions, maintaining clinical trial records, FDA submissions, and acting as a liaison between industry, grants and contracts, principal investigators, and the department administrator. 

Key Responsibilities:

• Serves as administrative lead for clinical  research.

• Work with DFA, clinical research manager and clinical trials finance coordinator to monitor and execute finance duties and assist in the long term strategy for sustaining clinical research in the department

• Provide oversight, direction and leadership for all clinical research operations within the department

• Hire, train, supervise, coach and direct team members

• Monitor, manage and deploy clinical research resources and FTE to department faculty and actively assess growth needs for personnel with in unit

• Provide oversight of Good Clinical Practice (GCP) in all studies

• Develop program/project goals and communicate goals and outcomes with a variety of stakeholders

• Participate in tactical and strategic program/project development and planning

• Participate in program/project budget development processes, including grant writing and submission processes, and regularly reviews to ensure alignment

• Lead and participate in program/project start up and close out functions

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 in Aurora, CO.

Why Join Us:

The Department of Ophthalmology is