Director, Clinical Trials Implementation & Coordination

Job Summary:

UW Clinical Trials Institute is a partnership between the University of Wisconsin School of Medicine and Public Health (SMPH) and UW Health. It supports clinical research professionals, investigators, and participants to advance discovery and research in the prevention, detection, and treatment of disease to help improve the health of individuals, families, and communities across Wisconsin and beyond. Our exceptionally talented and diverse workforce provides care, support, and provide information to clinical trials participants; resources, training, and guidance to research professionals; and opportunities for industry partners to advance groundbreaking medical research.

Supporting the mission and vision of the UW CTI, the Director of Clinical Trials Implementation and Coordination will manage clinical trials study activation and coordination across the UW Health and UW-Madison enterprise. They will provide oversight and management to the Portfolio Management Team, providing start-up management, and the clinical research coordinator teams providing study implementation and coordination services across the enterprise. Working directly with investigators and staff, they will ensure the appropriate use of resources, and the management of efficient study work. The Director of Clinical Trials Implementation and Coordination will work with senior leadership on strategy for the research portfolio and will ensure an adequately trained and staffed team to complete required study activities. They will be the primary contact with Principal Investigators (PIs) ensuring that studies are being completed on time and on budget and will work across the organization to mitigate potential compliance or implementation challenges.

The Director of Clinical Trials Implementation and Coordination will serve as a content expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem solving related to clinical, logistical, financial, and regulatory issues. They will maintain strong collaborative relationships with ancillary services, UW Health Nursing, UW Health Lab and operational staff in the clinics and hospitals in which we work. They will further work to ensure a research culture that encourages compliance, collaboration, efficiency and professionalism among all staff.

The incumbent should possess excellent time management skills, ability to work collaboratively, manage multiple projects despite interruptions, while closely tracking details and looking for ways to improve processes, have advanced communication skills, the ability to interface with multiple parties with competing interests, and demonstrated ability to work in multi-disciplinary teams.

Responsibilities:

Plans, develops, and directs a clinical research program within a division, center, or department. Solicits clinical research opportunities, develops policies and procedures, and has significant responsibility for the overall functioning and effectiveness of the clinical research. Supervises one or more Clinical Research Managers.

• 30% Plans staff implementation of protocols and on-going quality review of one or multiple highly complex clinical research trials or programs
• 15% Analyzes research portfolios and accounts, solicits internal and external research opportunities, promotes unit capabilities, and makes recommendations to leadership for strategic program enhancements
• 10% Compiles audits and documents research data to ensure necessary compliance with institutional policies and procedures
• 20% Exercises supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 full-time equivalent (FTE) employees
• 5% Develops and monitors the program budget; and reviews and approves expenditures
• 5% Drive and support strategic initiatives under the guidance of senior leadership to advance clinical research programs
• 10% Provide project consultations, trial updates, and budgetary considerations, while also serving as a liaison to ensure strong internal and external relations
• 5% Partner with training resources throughout the organization to establish a continuous education framework & training for clinical research coordinator & portfolio manager staff to ensure personnel are up-to-date and skilled

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricabl