Position Description:
Every great life-changing discovery begins the same way—with new knowledge. It can change everything, from a single life to the future of entire communities. That’s why academic medicine, and the continuous pursuit of knowledge, is at the center of everything we do at the Medical College of Wisconsin (MCW). In the role of Manager Clinical Research you will be working in the Cancer Center.
Purpose
This position is responsible for oversight and management of the Cancer Clinical Trials Office (CTO) Regulatory team in gathering regulatory documents and preparing applications for human subject research to ensure compliance with state, federal and institutional regulations, policies and procedures. The Cancer CTO Regulatory Manager will function as the regulatory liaison with sponsors, principal investigators, study team members, and the IRB, providing support to facilitate the achievement of the Cancer CTO’s goals.
Primary Functions
Functional manager representing the Cancer CTO Regulatory Team at meetings with partner organizations as well as internal Cancer CTO process discussions. Works collaboratively with principal investigators, sponsors, study team members as well as representatives in other departments and institutions, maintaining open communication.
A resource for investigators and support staff on pre-trial and ongoing trial maintenance functions including gathering of regulatory documents, safety committee reviews, assist with IND applications, IRB applications, trial amendments, annual progress reports, CT.gov applications and maintenance, etc. as specific to clinical trials. Advise department study investigators and support staff on administrative and regulatory aspects of human subject research.
Responsible for time, workload and performance management for the regulatory team in the Cancer CTO.
Recruit and train clinical research staff on regulatory issues; develop and implement standardized expectations for all subordinates; assess, monitor and evaluate work load and performance. Collaborate with Education/QA Coordinator on the development of training materials. Mentor and direct staff to achieve research goals.
Maintain protocol activation timeline including tracking deadlines for program components. Utilize MCW’s Clinical Trial Management System (CTMS) OnCore and other system to assist with meeting regulatory requirements and tracking activities. Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders
Manage other data systems, such as Florence, RightFax, and eBridge which support research activities. Correspond with local and central IRBs as needed.
Develop and implement Cancer CTO departmental policies, procedures and organizational tools to ensure compliance with MCW institutional standard operating procedures and procedural guidelines, state and federal standards.
Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators.
Act as a liaison between Department Administrator and research staff. Work closely with other departments and external agencies to advance the department’s research goals.
Develop, implement and monitor department research QI activities. Implement and conduct quality control processes to ensure the highest data and research standards.
Develop clinical review data review plan and check specifications. Utilize quality improvement tools & statistical process control to facilitate improvement of systems & processes.
Perform as a regulatory specialist/coordinator for select projects as needed.
Coordinate notifications to study team members regarding annual regulatory education requirements.
Coordinate program outreach activities acting as a liaison with community organizations, providing regulatory support for Community Memorial Hospital/St. Joseph’s Cancer Center in West Bend, Drexel Town Square Health Center, and others as applicable.
Knowledge – Skills – Abilities
Knowledge of basic science and mathematics, documentation, and records management. Working knowledge of e-Bridge, electronic IRB and Grants and Contracts functions. Excellent oral and written communication skills are essential. Strong critical thinking, problem solving and attentiveness to detail required. Strong computer skills. Sufficient knowledge of program study area. Strong leadership and staff oversight and management skills are critical. Data utilization, complex problem solving, critical thinking, resource management, and writing skills.
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Preferred Schedule:
Fulltime 8:00-4:30
Position Requirements:
Specifications
Appropriate experience may be substituted for education on an equivalent basis
Minimum Required Education: Bachelor’s degree
Minimum Required Experience: 6 years of experience in research program coordination or regulatory.
Preferred Education: Experience with program management in a medical research or educational environment preferred.
Preferred Experience: Prior work with clinical research or regulatory or patient care preferred.
Field: Science or Compliance
Certification: CCRC or CCRP required. CITI training required within 90 days of hire.
Why MCW?
- 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.
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