Director, Clinical Research Administration and Operations
Duke University 393 reviews - Durham, NC

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Director of Clinical Research Administration and Operations Duke Comprehensive Cancer Center Duke University is seeking a dynamic Director of Clinical Research Administration and Operations for the Duke Cancer Institute. The Director will report directly to the Associate Vice President for Duke University Health System’s Oncology Services and the Medical Director for Oncology Site-Based Research. The Director will also work very closely with the NCI-designated Comprehensive Cancer Center’s Deputy Director for Clinical Research, and the Chief Academic Administrative Officer responsible for basic science and the Cancer Center core grant to successfully administer the Institute’s Clinical Research Division. This senior management team approach and partnership are critical to the success of the mission of the Duke Cancer Institute and the Duke Comprehensive Cancer Center Core Grant. The Director will be charged with providing constructive and forward-thinking leadership for all components of oncology clinical research, including but not limited to pre-award research development, post-award research administration, staff education and training, health disparities and community engagement, regulatory compliance, IRB processes and issues, and clinical trials operations (accrual growth/management strategies, hospital/University partnerships, space, technology, and compliance). The Director will also oversee the Center’s NCI-designated shared resources supporting clinical research and lead initiatives to increase the quality and efficiency of these shared resources. Salary is commensurate with experience and academic preparation

Advanced degree in business administration, health administration, or a related discipline

CCRP certification required. Additional professional certifications preferred

Five or more years experience in a similar administrative leadership role within an academic health science center/University/Medical Center directly engaged in the administration of clinical research programs and clinical trials

Significant knowledge and involvement in the development of translational research programs, clinical research protocol review systems and processes, clinical trials operations, and regulatory compliance is required

Excellent overall knowledge and involvement in clinical research support functions (pre and post-award, sponsored programs administration and compliance, clinical trials management systems, safety desks, monitoring, protocol review, etc)

Excellent communication and leadership skills.

Highly collaborative and energetic management style

Experience with building strong partnership between university and health systems functions related to clinical research

Proven track record in increasing diversity of clinical trials populations, increasing community engagement/partnerships, and addressing health disparities is highly preferred

Job Duties:
Oversee the clinical research administration function of the Duke Cancer Institute and NCI-designated Comprehensive Cancer Center Core Grant.
Recommend and implement procedural and process changes to improve the effectiveness, efficiency and compliance of the clinical research mission.
In partnership with the Medical Director for the Oncology Site-based Research and Associate Vice President for Oncology Services for Duke Health System, oversee the administration of site-based and affiliated clinical research.

Supervise the Research Practice Manager and Finance Practice Manager of the Oncology Site-Based Research to enhance operational performance, increase the quality of support to clinical investigator, and strengthen regulatory and institutional compliance.
Lead efforts to increase diversity of clinical trial populations. Work with University and Health System leadership to increase clinical trial accruals with specialized effort to increase the accruals of minorities and under-represented communities.
Develop internal educational and training programs/standards centered around improving clinical research administrative services, engaging community involvement in the education of the benefits of clinical research, and participating in targeted outreach and education efforts with external audiences.
Provide strong leadership in the development, implementation and improvement of clinical trial management systems and patient population screening tools/systems.
Represent Duke University at professional organizational meetings, conferences and symposiums. Serve in external leadership capacities within professional organizations.
Through continuous improvement, identify, communication and implement best practices for clinical research administration.
Be an advocate for clinical researchers in working with the IRB and other University-based committee and processes engaged in clinical research. Help resolve issues between IRB and clinical investigators.
Promote translational and collaborative research. Advise leadership on barriers and opportunities for improvement.
Oversee the operations of the clinical trials shared resources within the Duke Comprehensive Cancer Center Core Grant. Work with the Shared Resources Committee to address operational and performance issues of the shared resource, labs and services.
Work in partnership with the Director of Basic Research to streamline operational functions and services. Ensure compliance to NCI standards and requirements associated with the Center’s NCI designation as a Comprehensive Cancer Center. Participate in the oversight of the Cancer Center Support Grant as it relates to clinical research and provide input for progress report development and grant application preparation.
Other duties as assigned. Minimum Qualifications
Education Bachelor's degree in nursing, pharmacy or other allied health care discipline including appropriate certification/licensure (i.e., RN, PA, or RPh) required. OR Bachelor's degree in a life science field (i.e., biology, chemistry, zoology, etc.) acceptable for those candidates who possess a minimum of 10 years directly related experience and extremely strong clinical knowledge. Prefer a Master's degree or other post-graduate training in a clinical discipline or business/health care administration (MSN, PharmD, PhD, MD, MBA, MHA, MPH).
Experience 7 years of experience in clinical trial operations in an academic medical center, or in the pharmaceutical, medical device, biotechnology, or contract research industry. 3-5 years in a project management capacity and 1-2 years in a personnel management capacity (of professional/ technical/ clinical staff). Strongly prefer experience in a variety of therapeutic areas and in managing large international trials. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

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