Manager Clinical Research - Herma Heart Institute - Pediatrics

Overview

Manage all aspects of clinical trial initiatives within the Herma Heart Institute to ensure compliance with state, federal and institutional regulations, policies and procedures.

• Act as a resource for investigators and support staff on clinical pre-trial functions including budget development, contract negotiations, IRB applications, FDA regulations, and grant development. Advise department study investigators and support staff on administrative and regulatory aspects of human subject research.
• Develop and implement department policies, procedures and organizational tools to ensure compliance with MCW, state and federal standards. May act as a liaison between primary investigator (PI) and sponsors on regulatory quality control and quality assurance matters.
• Manage data systems supporting research activities. Correspond with IRBs as needed.
• Partner with business manager in the development and management of clinical research budgets. Maintain understanding of the research project budgetary requirements.
• Manage Clinical Research Coordinator team within Herma Heart Institute. Recruit and train clinical research staff, nurses, and clinical research coordinators; 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 internal and external clinical research operations teams. Work closely with other departments and external agencies to advance the Herma Heart Institute research goals and initiatives.
• Develop, implement and monitor clinical research 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 and statistical process control to facilitate improvement of systems and processes.
• Perform as a study coordinator for select projects.
• Document clinical research activities. Generate monthly updates on activities and annual reports on research accomplishments.
• Facilitate timely review and processing of research study proposals. Assemble ad hoc committees as needed.
• Support investigator and staff access to research core resources via the Children’s Research Institute and the CTSI of Southeastern Wisconsin.
• Partner during the transition of basic science or translational research into clinical practice.
• Remain informed about developments and innovations in the field of pediatric Cardiothoracic Surgery and Cardiology research, research tools, and techniques.
• Perform other duties as assigned.

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

Minimum Required

Education:

Bachelor’s degree.

Minimum

Required Experience:

6 years of clinical research experience

Preferred Education: Master’s preferred in a scientific field or healthcare management

Preferred Experience: 6 years of direct clinical research coordinator and operations experience

Required Certification/Licensure(s): CCRC or CCRP required. CITI training required within 90 days of hire.

Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.

• 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
• Employee & Family Assistance Program (EFAP)
• 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 brief overview of our benefits see:
Benefits Overview

For a full list of positions see: MCW Careers

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