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SR. DIR., CLINICAL RESEARCH OPS
Job Title: SR. DIR., CLINICAL RESEARCH OPS
Job Code: 1632
FLSA: E
Job Level: 18
Revised Date: 09/10/2024
Job Family: JF 28
Occupational Summary
The Senior Director for Clinical Research at Duke University School of Medicine (SOM) provides senior operational leadership for key clinical research operations support. Reporting to the Associate Dean for Clinical Research, this individual collaborates closely with the Vice Dean for Clinical and Translational Research, Associate Dean for Clinical Research Initiatives, Associate Dean & Executive Director Regulatory Affairs & Quality, Senior Director for Clinical Research Initiatives, and other executive leaders to implement operational initiatives across the SOM and in partnership with other Duke University entities. The Senior Director fosters effective relationships with colleagues within the SOM, Duke Health, and other stakeholders across Duke. Their responsibilities include overseeing the implementation of clinical research operational plans, developing innovative programs or services supporting clinical research, and ensuring regulatory compliance and adherence to associated budgets. Additionally, they contribute to research presentations, manuscript preparation, and grant assistance.
Work Performed
Strategic Leadership:
Oversee the implementation of strategic plans for clinical research with SOM clinical research units.
Manage the operations of the start up, conduct, close out, including day to day operations of DEPRU and DOCR Service Centers.
Liaise and partner with Duke Health, DUHS Compliance, OASIS, DHTS to execute embedded health system research and other research/development initiatives.
Oversee the management of clinical systems (such as OnCore, Epic, Maestro Care, eReg) to support clinical research teams.
Advise on the selection of new and/or upgraded software to augment the clinical research workflow.
Represent Duke in local and national professional associations by serving on committees and presenting at conferences; stay current.
Partnerships and Collaborations:
Develop and maintain relationships with clinical trials participants, including researchers, clinicians, university administration, Food and Drug Administration (FDA), and industry sponsors.
Assist in developing strategic partnerships across the SOM and Duke Health or affiliated systems for clinical research. Oversee existing and proposed expansions of research within the SOM.
Service Center Clinic Operations Oversight:
Oversee strategy and operations of the DEPRU and DOCR Service Centers Provide direction for business development for DEPRU CRU.
Prioritize new projects and maintain sponsor relationships, including clinical trials conducted outside the United States.
Coordinate clinical trial schedules, task assignments, and resource allocation to meet specified objectives.
Perform development and fundraising activities.
Clinical Research Operations and Institutional Effectiveness:
Implement and develop operating policies and procedures for DOCR.
Conduct meetings with staff to ensure compliance with established practices and communicate changes and standards.
Monitor and analyze institutional effectiveness using evaluation tools and dashboards specific to clinical research.
Prepare reports and analyses reflecting progress, adverse trends, and recommendations.
Assist with data analysis and research presentations.
Collaborate with study teams, research practice managers, statisticians, and investigators to:
Determine study design feasibility.
Ensure adequate quantitative assessment (e.g., informatics, data management).
Provide subject recruitment recommendations.
Insure data provenance and collection.
Coordinate with IT for data storage and services.
Personnel Management:
Oversee personnel functions, including hiring, merit recommendations, promotions, transfers, and vacation schedules.
Coordinate work with research and business operations managers to provide efficient service to investigating teams.
Required Qualifications at this Level
Education/Training
Bachelor degree required; graduate degree in business administration, health administration, public health, or health related field preferred. A working knowledge of health care and clinical research.
Experience
Minimum of 10 years of management experience required, preferably in a highly complex, matrixed organization such as an academic medical center, medical school teaching hospital, or research university.
Skills
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, (including pregnancy and pregnancy related conditions), sexual orientation, or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
