Manager, Clinical Research

Department Details

The Manager – Clinical Research will provide operational leadership within the Center for Clinical Epidemiology & Population Health (CCEPH) at Marshfield Clinic Research Institute. CCEPH conducts nationally recognized research in vaccine safety and effectiveness, infectious disease, chronic disease prevention, cancer care and outcomes, and other areas that advance patient and population health.

Working closely with investigators, project managers, and research staff across multiple Wisconsin locations, this manager will oversee staff and day-to-day research operations, coordinate resources across studies, and support the successful delivery of a diverse research portfolio. This role offers an opportunity to develop a skilled team of Research Coordinators and Research Assistants and strengthen the operations behind research that informs clinical care and public health.

Summary

Responsible for providing clinical and administrative leadership to assigned region’s facility and practice operations. Implements the vision, mission and strategic plan of clinical research in conjunction with the health services division. Manages staff and activities for the clinical research department with an operational focus.

Job Description

• Assists in the development, planning and implementation of a system approach to improving and maintaining standards in clinical research operations.
• Establishes communication and develops meaningful and collaborative working relationships throughout the clinical research team and health service departments.
• Ensures the completion of study activities in compliance with protocol and the regulations governing clinical research.
• Ensures study staff acquires appropriate training and certification for regulatory and safety requirements; monitors staff in regards to compliance and competence as required by the position.
• Provides quality assurance checks to ensure accuracy and compliance with rules and regulations in the conduct of clinical research trials.
• Evaluates regulatory agency reports and audits, and formulates responses and corrective action plans.
• Creates policies and procedures, and designs site specific tools to enhance efficiency and accuracy in completing study tasks.
• Supports project initiatives and works closely with key stakeholders and physicians for implementation and support of clinical trials.
• Communicates study needs and concerns in a timely manner.
• Serves as the liaison with community partners to communicate program objectives, encourage recruitment and ensure compliance with study protocol.
• Occasional travel between sites may be required.

Qualifications

Bachelor's degree in nursing, biology, psychology, microbiology or related field required. Master's degree preferred.

Dependent on research facilities/laboratories, leadership may independently require employees to have a bachelor’s in nursing and have been a graduate from a nationally accredited nursing program preferred, including, but not limited to, Commission on Collegiate Nursing Education (CCNE), Accreditation Commission for Education in Nursing (ACEN), and National League for Nursing Commission for Nursing Education Accreditation (NLN CNEA).

Clinical or clinical research experience required. Two years management/leadership experience preferred.

Certification through Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) required. Certification must be obtained within three years from hire date.

If research facility/laboratory requires a nursing license, must hold an unencumbered RN license with the State Board of Nursing where the practice of nursing is occurring and/or possess multistate licensure if in a Nurse Licensure Compact (NLC) state.