Manager Clinical Research - Herma Heart Institute / MCW CSG Shared Services

Position Description :

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

Purpose

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

Primary Functions

• 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 innovation in the field of pediatric Cardiothoracic Surgery and Cardiology research, research tools, and techniques.
• 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, innovative thinking, computer and writing skills.

#LI-AV1

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

Preferred Education : Master's Degree in a scientific field or healthcare management

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

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.