Research Operations Manager 2 - Lillehei Clinical Research Unit

About the Job

The Primary purpose of the position is to lead the clinical research program and infrastructure of the Lillehei Clinical Research Unit (LCRU) in collaboration with the LCRU Deputy Director and LHI leadership. The LCRU is a clinical research unit within the Lillehei Heart Institute (LHI). The Program Director will assure the operational efficiency of research by proper equipment, procedural oversight of data collection and analysis, and development and maintenance of budgets. The Program Director will provide strategic direction and oversight for research operations including portfolio growth, staffing, resources and fiscal responsibility of the unit.

(25%) Strategic Direction of the program Develop and implement processes and procedures to ensure that services are provided to the Cardiovascular investigators in an efficient, integrated and high quality manner to meet the clinical and research objectives of the Lillehei Clinical Research Unit (LCRU). Manage the budget, human resources, physical resources, operational policies and procedures, and other administrative activities of the integrated service. Work collaboratively with the Medical School, the Clinical Translational Research Institute (CTSI), M Health Fairview and University of Minnesota Physicians to serve the needs of cardiology patients and researchers.

(15%) Strategic Planning and long-range growth Participate in long-range planning, including strategic growth planning, for support of the LHI. Serve as a member of the division's Clinical Research Leadership team to participate in development of research priorities and the resources necessary to accomplish the division's mission. Responsible for developing and implementing tactics to meet strategic goals.

(20%) Collaboration across a large matrix organization Partners with other offices and committees within the University of Minnesota, Office of Academic Clinical Affairs, Clinical Translational Science Institute, University of Minnesota Physicians, and M Health Fairview to facilitate change and to make recommendations for improving research compliance and processes. Exemplify the mission of the department's initiatives with clinical partners. Represent the Cardiovascular division in the development and implementation of Medical School wide clinical research policies and procedures.

(40%) Direct and oversee daily operations of the LCRU personnel. Management and training of all non-physician staff. Recommends the hiring of new staff and ensures proper orientation and training is provided. Writes and updates job descriptions, makes decisions regarding employee requests, delegate’s duties, conducts staff meetings, coordinates and conducts performance appraisals, monitoring progress and attainment of mutually agreed upon goals for direct reports. Facilitates the development of new and existing staff through individual and institutional activities.

Fiscal Responsibility: Supports the development of the annual budget including ISO rate development and assists leadership and finance managers to develop capital purchases. Responsible for budget monitoring to manage and control expenditures. Mentors and directs staff to maximize resources efficiently. Maximizes cost efficiencies in the development of supply, equipment and inventory systems, managing operations and ensuring compliance within established budget targets for respective accounts.

Policies and Procedures: Development of policies and procedures to promote adherence to Good clinical practices, Code of Federal Regulations and University and Fairview policies. Promotes adherence to regulatory requirements to ensure safety of study participants and employees.

Qualifications

Required Qualifications: Requires BA/BS with at least 8 years experience managing/leading clinical studies/teams in a supervisor leadership capacity or an advanced degree with 6 years’ experience managing/leading clinical studies/teams in a supervisor leadership capacity. Experience managing direct reports and leading clinical research teams. Clinical Research experience in an Academic or Business and Industry setting. Expertise with Good Clinical Practice, Code of Federal Regulations, regulatory and compliance guidelines for clinical trials. Experience with using MS Office suite applications

Preferred Qualifications: Experience using REDCap, Smartsheet, ETHOS and OnCore. Cost-center/budget management experience. Experience managing clinical trials from start to finish. Grant funded trials as well and business and industry (medical device and pharmaceuticals). Leadership skills include strong communication, problem solving, business integration across cross functional teams, and quality focused. Experience in Cardiovascular research