Associate Director or Director of Clinical Research

Associate Director or Director of Clinical Research-33685University Staff

Description

University of Colorado Anschutz Medical Campus

Department : Gates Institute

Job Title : Associate Director or Director of Clinical Research

Position # : 00805395 Requisition # : 33685

Job Summary :

The Gates Institute is seeking a full time Associate Director or Director who will be primarily responsible for establishing the strategic direction and tactical approach to operationalizing clinical trials by focusing on the people and processes.

The Associate Director or Director will be a senior member of the Gates Institute’s leadership team; they will build and maintain strong and impactful relationships, while working cross-functionally and collaboratively to oversee planning, management, and execution of trial activities.

At the Director level, this role will strategically lead clinical research operations for the Gates Institute, including oversight of mission critical strategic planning, finances, and human resources, with guidance from the Director of Finance & Administration of the Gates Institute.

Key Responsibilities :

Leadership and Strategy (20%) :

• Champions the development and execution of a strategic and tactical plan to operationalize clinical trials for each Gates Institute product by providing expertise, leadership, strategic planning, and financial oversight.
• Designs a cascading goal setting and performance infrastructure that ensures individual alignment to the strategic plan and fosters personal and professional growth.
• Develops and implements Gates Institute guidelines and policies in the sector of clinical research, and ensures projects are appropriately resourced.
• Recruit, supervise, develop, and mentor members of the Clinical Research team including hiring, compensation, termination, and performance, with the guidance from the Director of Finance & Administration.
• Partners with relevant campus clinical research leaders to establish standardized processes for performing high quality clinical trials within their functional areas as warranted by the Gates Institute product portfolio.

Director Level : In addition to the duties above

• In support of the mission of the University of Colorado, Anschutz Medical Campus, this role will lead clinical research initiatives and manage long- and short-term strategic planning in direct support of ongoing clinical trial advancements and operations.
• Manage strategic staffing for Clinical Trials team.
• In collaboration with Gates leadership, this role will be responsible for financial planning and projections, budget development and management, year-end budget analysis and close-out, etc.

Communication and Education (20%, Both Levels) :

• Develops and provides education to site teams and other stakeholders on phase 1 clinical trial protocols and standardized processes.
• Provides a channel of communication between teams specializing in preclinical work, manufacturing, and clinical work, including trial design, safety and regulatory oversight, data management, and execution of clinical trials.
• Establishes and maintains communication and collaboration with the key stakeholders in the office of the Vice Chancellor for Research regarding issues relevant to patients and projects associated with the Gates Institute.
• Work with Gates Institute Communication Manager to communicate trial milestones internally and externally, as appropriate.

Operations and Continuous Improvement (20%, Both Levels) :

Works with the disease specific clinical research teams to develop study flows consistent with the protocol and clinic level practices.

Reviews new protocols and amendments for patient inclusion and operational feasibility. Ensures protocol procedures are feasible in the local clinical environment.

• Develops and strengthens resources, programs, and services to optimize clinical research with a continuing focus on process and quality improvement.
• Identifies, tracks, and analyzes barriers in current clinical trials processes and conceptualizes and executes process improvements.

Clinical Trial Management (20%, Both Levels) :

• Serves as trial development and trial management lead, collaborating with scientists, Principal Investigators, physicians, scientific writers, site teams, regulatory compliance, manufacturing experts, and other entities on campus to bring Gates Institute products successfully and efficiently to patients.
• Develops study support materials including lab manuals, protocol-related procedure forms, case report forms, needed appendices, investigator’s brochures, etc. as needed.

Patient Safety Oversight (20%, Both Levels) :

• In collaboration with Gates Institute Medical Lead(s), verifies patients meet all eligibility criteria; verifies and reviews adverse events, serious adverse events, and other trial data, and ensures accurate reporting in accordance with the protocol.
• Tracks, documents, and updates stakeholders on status of study participants.
• Reports adverse event data to relevant stakeholders, including Safety Monitoring Committee.

Work Location :

Hybrid this role is eligible for a hybrid schedule of 2 days per week on campus located in Aurora, CO and as needed for in-person meetings.

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