Clinical Research Program Director-37288University Staff Description

University of Colorado Anschutz Medical Campus Department: Cancer Center

Job Title: Clinical Research Program Director

Position #: 00758283 – Requisition #: 37288 Job Summary: The University of Colorado Cancer Center is seeking a full time Cancer Clinical Trials Office Program Director to provide leadership and oversight to oncology clinical trials operations focused on the Cancer Clinical Trials Office (CCTO). This work falls under the auspices of the Cancer Center’s Cancer Protocol and Data Management (CPDM) component. The CPDM provides coordination of the Cancer Center’s clinical research activities.

In collaboration with the Assistant Director of Clinical Research, CCTO Medical Director and other CU Cancer Center research leadership, this position will provide oversight and coordination for clinical trial activity conducted by the CCTO which conducts clinical trials on the Anschutz Medical Campus and Denver Metro area UCHealth sites and in partnership with regional UCHealth sites in Northern and Southern Colorado.

Examples of Work/Essential Duties :

Clinical Research Operations (40%) Optimize clinical research program results by improving CCTO administrative, operational and financial performance related to clinical research and resolving problems through the independent exercise of judgement and discretionary decision-making authority.

Develop and strengthen resources, programs and services that facilitate clinical research operations within the CCTO with a continuing focus on quality improvement, cost-effectiveness and productivity enhancement.

Evaluates and coordinates improvements in processes to maintain performance.

In collaboration with the CCTO management, provides leadership, and oversight for operations of the CCTO by coordinating across functions (pre-award budget development, contract routing, regulatory submission, trial implementation, etc) and systems (clinical trial management system, reporting systems, etc) to optimize the trial process.

Optimizes performance of clinical trials management system (OnCore) and eREG processes and develops metrics to assess performance for CCTO clinical, regulatory and finance staff as well as advises other CU Cancer Center partners on process improvement in utilizing technology platforms

Provide clinical research operations leadership within the CU Cancer Center and expertise to the UCHealth regional sites.

Partners with clinical research leaders to establish standardized processes for performing high quality oncology clinical trials across the Front Range Clinical Trials Network. Leadership and Strategic Planning (40%) Participates in the strategic decision-making process relevant to clinical research through leadership as a member of the Clinical Research Leadership Team.

Establishes and maintains communication and collaboration with respective operational leaders at UCHealth Research Administration, UCHealth Oncology Service Line, the University of Colorado Anschutz Medical Campus Office of the Vice Chancellor for Research and the Oncology Clinical Research Support Team (OCRST) regarding issues relevant to patients participating in clinical trials conducted across the CU Cancer Center.

Provides input for the development of and review of CU Cancer Center guidelines and policies.

Collaborates with the CU Cancer Center Assistant Director of Clinical Research, the Program Director of OCRST, the Assistant Director of Research Administration to achieve clinical research administration goals as delineated in the CU Cancer Center Support Grant (P30), including participating in the writing and editing of relevant sections of the grant and annual progress reports, and participation in the NCI site visit.

Develops effective partnerships with the Clinical Research Administration Office (CRAO), OnCore team, CCTSI (CTSA-grant holder), Investigation Drug Service, and UCHealth Research Administration and Oncology Service Line leadership among others.

Establishes a collaborative working environment with member institutions under the UCHealth system and communicates with Assistant Director of Clinical Research, CCTO Medical Director and Leadership team regarding all issues related to research.

Supports the development of effective and collaborative partnerships with pharmaceutical companies, Contract Research Organizations (CROs) and others to establish CU Cancer Center as a premier clinical research site.

Works with CU Cancer Center Assistant Director of Clinical Research, UCHealth Research Administration leadership and others as needed to support the continued growth of the Front Range Clinical Trials Network (FRCTN), by coordinating the financial and regulatory process to open clinical trials across the UCHealth system. Financial Responsibilities (20%) Collaborates with the CU Cancer Center Assistant Director of Finance in developing accurate projections of expenses, budgetary, and staffing needs and makes recommendations to CCTO management and the CCTO Medical Director as appropriate.

Works with the CCTO managers and the CU Cancer Center Assistant Director of Clinical Research and Assistant Director of Finance to develop metrics to support resource allocation decisions and develop annual budget requests. Work Location: Hybrid – this role is eligible for a hybrid schedule of at least 3 days a week on campus and as needed for in-person meetings. Why Join Us