Associate Director, Clinical Research Unit

Duke Careers - Durham, NC

Full-time
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health . Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

OCCUPATIONAL SUMMARY

Department of Medicine Office of Research – Clinical Research Unit
Working title: Associate Director, Clinical Research Unit

Occupational Summary
The Associate Director is responsible for high-level oversight and effective management of the administrative and operational components of the Department of Medicine Clinical Research Unit (CRU), to include accountability for all human subject research provided through research activities and financial performance of the research groups within the Medicine CRU.

The Associate Director has dual reporting, serving as an organizational partner to both the Medical Director and the Administrative Director of the Medicine Office of Research. The unified partnership is integral to achieving the strategic vision and goals of the Medicine CRU and Office of Research . The CRU Associate Director will provide support to the operational and financial staff in the CRU with direct reporting from the Research Practice Manager(s) (RPM) and Finance Practice Manager(s) (FPM) and their reporting lines.

In addition, the Associate Director will lead innovations and initiatives for improving the CRU user experience, addressing feedback on performance concerns of staff and the overall CRU. This is a departmental administrative leadership position that will focus on improving the function, efficiency, and service provided by the CRU and developing new programs and initiatives that address challenges encountered in the clinical research mission. The position will be responsible for administering the CRU allocation model and, in coordination with the Administrative Director, development of annual operating budget.

Work Performed
Facilitate clinical research across and within disease based Medicine CRU clinical trials groups across various locations.

Accountable to meet and exceed operational plans by continuous improvement. Lead the prioritization of initiatives for improvement within established goals, and implement organizational strategies and plans for improvement of services.

Ensure appropriate commitment of key stakeholders in the development of strategic planning to ensure success of the CRU. Partner with stakeholders at all levels of the organization to mitigate obstacles that may affect the ability to meet CRU targets and objectives. .

Prepare the CRU for future growth and quality. Create a climate of effectiveness and efficiency to foster satisfaction of faculty. Enable and advance innovation.

Develop and coach CRU leadership team to pursue organizational decisions conducive to transformation. Continue to foster positive work culture for CRU staff.

Deliver positive change through effective project management, problem solving, change management and effective training.

Implement new plans, programs and structural changes necessary for the success of the CRU. Examine and refine CRU operations; seek and apply best practice methods to improve research quality, efficiency and productivity. Update and implement business plans.

Develop, clarify and implement administrative and operational policies in support of clinical research conducted in the Department of Medicine. Ensure compliance with policies set forth by the institution, the department and external agencies. Conduct meetings with staff to ensure compliance with established practices, to implement new policies and to keep employees abreast of current changes and standards.

Oversee the day to day financial management aspects of clinical research support related to study conduct including financial feasibility, budget development and negotiation, resource allocation, and revenue management of studies to include invoicing, enrollment monitoring and accounts receivable management.

Develop liaison with other offices involved in clinical research and research administration, Represent and advocate for the Medicine CRU on school-wide workgroups and committees.

Coordinate the development of reports to analyze the success of the Medicine clinical research enterprise and improvement initiatives.

Plan and prioritize work for the Medicine CRU ensuring proper assignments and adequate resources for performance of duties. Identify staffing needs for new initiatives. Facilitate training of staff for new initiatives.

Accountable for activities in accordance with all institutional standards for study conduct, and more specifically those relating to clinical research, provide information to the Duke Office of Clinical Research (DOCR).

Ensure that research activities are performed in accordance with Good Clinical Practice standards, and compliant financial management, Duke policies and procedures, and applicable regulatory requirements.

Monitor the progress of start-up timelines and key milestones for new studies, including IRB approval, contract negotiations, budget & payment terms negotiation and development of the OneDuke Budget.

Monitor the progress of ongoing studies including enrollment, data collection, financial performance and closeout.

Identify barriers to the successful outcome of projects, implement appropriate interventions.

Education and Experience
Bachelor's degree and 7 years of related experience. The ideal candidate would have significant experience in clinical research – someone who knows what site-based research is like from start to finish, both from an operational and financial basis and has worked his/her way to a successful leadership role. Knowledge of Duke systems preferred, but not required (e.g., iRIS, MaestroCare, OnCore, SPS, etc.).

Necessary Skills Must demonstrate strong understanding of policy and practice governing clinical research operational and administrative compliance within a large institution. Possess the ability to make decisions and operationalize evolving policy with significant, broad implications for the management and operations of a major department. Deep understanding of the mechanics of academic site based research as a team builder/leader. Experience working successfully with research faculty and their clinical research staff. Demonstrated managerial and analytical capabilities to effectively manage large and highly visible projects/teams. Ability to address problems that are broad, complex and abstract that require creativity, resourcefulness, staff engagement, and diplomacy to solve. Robust experience hiring, managing, and motivating staff; ability to effectively delegate and prioritize work and balance workload assignments; ability to manage the completion of a high volume of work, some of which is cyclical. Must be able to function independently and have a clear understanding of accountability. Significant grasp on appropriate escalation when issues arise. Ability to independently meet deadlines; experience holding a position in which being a self-starter was essential. Superb interpersonal, supervision and communication skills including tact, diplomacy and flexibility; ability to communicate both verbally and in writing with all levels of the organization.

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