Clinical Research Manager - Pediatric Critical Care and Infectious Disease

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 Manager Clinical Research you will be working in our Pediatrics Department.

Purpose

Manage all aspects of clinical trial initiatives to ensure compliance with state, federal and institutional regulations, policies and procedures for multiple divisions including Pediatric Critical Care and Pediatric Infectious Disease. Partner to develop additional research opportunities and design and develop data needs as well as oversee IRB submissions.

Primary 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.
• Participate on appropriate committees relevant to the advancement of the program and the profession or area of research.
• Develop and implement department policies, procedures and organizational tools to ensure compliance with MCW, state and federal standards.
• Manage data systems supporting research activities. Correspond with IRBs as needed. Management of clinical trial activities.
• Oversee compliance with all relevant IRB and other regulatory agency requirements. includes budget/feasibility preparation and reporting to funding agencies as required to ensure the success of additional resource requests.
• Assist in the development and management of budgets, including submission and eBridge functions.
• Recruit clinical research coordinators and clinical research assistants. Train and orient staff (including nurses or other clinical providers) in research protocol compliance. Develop and implement standardized expectations for all subordinates. Assess, monitor and evaluate work load and performance. Mentor and direct staff to achieve research goals.
• Act as a liaison between Physicians and their respective study teams, Division Administrators and research staff. Work closely with other departments, divisions and external agencies to advance the department's research goals.
• Oversee the collection, analysis, and dissemination of program data. Organize internal and external meetings, site visits, and special events. Ensure program data and progress are reported to program stakeholders. Oversee division research database needs including collecting and analyzing data and identifying trends. Provide reports to division leadership.
• 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. Oversee program timeline including tracking deadlines for program components. Maintain timeline for all clinical trials including tracking deadlines for program deliverables.
• Perform as a study coordinator for select projects.
• Perform other duties as assigned.

Knowledge - Skills - Abilities

Knowledge of biology, chemistry, mathematics, documentation, and records management. Data utilization, complex problem solving, critical thinking, resource management, and writing skills.

Preferred Schedule:



Full-time role with expectations for coverage during core business hours and flexibility required as necessary to accommodate business needs.

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

Certification: 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

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 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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