The Medical College of Wisconsin (MCW) brings a synergy between the best medical education, research and patient care. Tomorrow’s discoveries happen right here alongside the very people who bring those lessons to our students. Every bit of knowledge, and every advancement, provides our students with an unprecedented, collaborative learning environment, and helps improve the vitality and care of our communities. In the role of Program Director I you will be working in the Cancer Center.
Work independently under the direction of the Cancer Center Clinical Trials Office (CTO) Director to manage all aspects of the cancer center clinical research operations and coordinate activities, processes and procedures of the disease team managers, their staff and clinical support positions. Serve as a catalyst for clinical research operational initiatives and ensure compliance with institutional, state, and federal regulations. Provide direction and guidance to the CTO disease team managers and program coordinators to facilitate the achievement of the program’s goals. Work collaboratively with our health partners to create and maintain a structure to provide an efficient and transparent process that allows for growth of the clinical research program into the future.
• Provide supervisory oversight, training and development of clinical research managers and operational support staff in the Cancer Clinical Trials Office.
• Assist Cancer Center CTO Director in developing and managing the clinical operations program budget and strategic planning initiatives.
• Act as resource for CTO disease team managers, faculty investigators and clinical partners in the determination of project feasibility, logistics and overall operationalization.
- Review, approve and oversee study budgets, contracts, regulatory and administrative documents. Develop timelines and negotiate deliverables to ensure a timely, on-budget study.
• Act as a liaison to the investigators and partners by representing the CTO at clinical operational meetings.
• Ensure compliance with regulatory and institutional policies.
• Develop and implement clinical operations policies, procedures, and organizational tools to ensure compliance with MCW, state and federal standards. Analyze and develop study protocols to establish best clinical practice.
• Coordinate the development of program materials including educational materials, marketing materials, websites, forms, and reports.
• Maintain program timeline including tracking deadlines for activation and accrual objectives, trial portfolio balance and program deliverables.
• Organize internal and external meetings, site visits, and special events related to clinical trial operations.
• In conjunction with the CTO Education and Quality Assurance Manager, assist in development of clinical operations training for program participants.
• Ensure program data and progress are reported to the CTO Administrative Director and CTO Medical Director as well as partners, as appropriate.
• Participate on appropriate committees and national forums relevant to the advancement of the MCW Cancer Center Clinical Trials Office.
• Oversee recruitment, screening, and enrollment process of study subjects.
Knowledge – Skills – Abilities
Knowledge of cancer clinical care, clinical cancer research implementation, regulation, and compliance, technical, business, consultation, project management, and cultural awareness. Knowledge of biology, chemistry, mathematics, documentation, and records management. Data utilization, complex problem solving, critical thinking, resource management and writing skills. Customer focus, building trust, communication, critical thinking, and influencing skills.
08:00 a to 4:30 p
Appropriate experience may be substituted for education on an equivalent basis
Minimum Required Education: Bachelor’s degree
Minimum Required Experience: 10 years
Preferred Education: Masters preferred
Preferred Experience: Highly experienced in program management in clinical research. Prior work with clinical trials management including emphasis and expertise with feasibility, logistics and operations. Previous personnel management of a large clinical research team preferred.
Field: Science based education. Coursework in research or project management preferred.
Certification: CCRC or CCRP required. CITI training required within 90 days of hire.
- Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
- 403B Retirement Package
- Competitive Vacation and Paid Holidays offered
- Tuition Reimbursement
- Paid Parental Leave
- Pet Insurance
- On campus Fitness Facility, offering onsite classes.
- Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.
For a full list of positions see: www.mcw.edu/careers
For a brief overview of our benefits see: https://www.mcw.edu/departments/human-resources/benefits
Eastern Wisconsin is a vibrant, diverse metropolitan area. MCW is intent on attracting, developing, and retaining a diverse workforce and faculty body that reflects the community we serve. We value diversity of backgrounds, experience, thought, and perspectives to advance excellence in science and medicine. MCW is a welcoming campus community with a strong culture of collaboration, partnership, and engagement with our surrounding community. For more information, please visit our institutional website at https://www.mcw.edu/departments/office-of-diversity-and-inclusion.
MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination
The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering a diverse community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.