CTO Disease Team Research Manager

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 a CTO Disease Team Research Manager you will be working in our Cancer Center.

Purpose

Manage all aspects of one of the Cancer Clinical Trials Office Teams with focus on Early Phase (Phase I, First in Human) trials for Solid Tumor types. Will be a catalyst for clinical research initiatives and ensure compliance with institutional, state, and federal regulations, policies, and procedures. The Clinical Research Manager will provide direction regarding clinical research efforts and resource management as a member of the Disease Oriented Teams and may be asked to provide oversight of additional designated CTO functions.

Functions

• Act as a resource for investigators and support staff on pre-trial functions including budget development, contract negotiations and IRB applications. Advise department study investigators and support staff on administrative and regulatory aspects of human subject research.
• Project (protocol) management. Act as liaison to the Disease Oriented Teams and Principal Investigators to ensure a collaborative atmosphere and guide the processes for protocol approval providing research support and management as appropriate following current MCW and Cancer Center CTO policy, procedures and guidelines.
• An active member of CTO Leadership team with focus on collaboration and continuous process improvement.
• Manage the disease team resources to provide adequately trained staff, project staffing needs, assign projects, and monitor staff performance.
• Develop and implement department policies, procedures and organizational tools to ensure compliance with MCW, state and federal standards.
• Manage data systems supporting research activities including, but not limited to, EPIC, OnCore, Florence, and eBridge. Correspond with IRBs as needed.
• Assist in the development and management of budget.
• Recruit and train clinical research staff nurses and clinical research coordinators; develop and implement standardized expectations for all subordinates; assess, monitor, and evaluate workload and performance. Mentor and direct staff to achieve research goals following all relative policies, procedures, and guidelines.
• Assist in process development and support for the ongoing implementation and use of the clinical trial management system, OnCore.
• Act as a liaison between Cancer CTO Administration and research staff. Work closely with other departments and external agencies to advance the department's research goals. Collaborate with MCW Office of Research, Grants and Contracts, IRB and other offices and committees to define processes and insure consistency.
• 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 Study Coordinator for select projects and / or patients if needed.

Knowledge - Skills - Abilities

Knowledge of biology, chemistry, mathematics, documentation, and records management.

Data utilization, complex problem solving, critical thinking, resource management, and writing skills.

#LI-AV1

Preferred Schedule : M-F 8-4 : 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 clinical research experience with an emphasis on pharmaceutical phase one trials

Preferred Education : Master's preferred

Preferred Experience : Experience with program management in a medical research or educational environment preferred. Prior work with oncology clinical research and patient care preferred

Field : Nursing or other science / medicine-based education. Coursework in project management preferred

Certification : CCRC or CCRP required. CITI training required within 90 days of hire.

Why MCW?

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

At MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values : Caring - Collaborative - Curiosity - Inclusive - Integrity - Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you.

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 an inclusive 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.