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Purpose:  To provide operational oversight for Duke Cancer Network affiliated research programs in order to maintain oncology research standards and support research activities within Network Services.

Scope of responsibility:  The Director of Clinical Research provides education, implementation strategies, and monitoring to ensure adequate performance of key research functions. The Director oversees and facilitates the work of the DCN research team to ensure performance and execution of DCN clinical research goals in compliance with local, regional, and national rules and regulations. The Director collaborates with the DCN Medical Director and AVP of the DCN to determine strategy and priorities within the DCN Research portfolio.  Additionally, the Director provides consultative support focused on quality research performance emphasizing Good Clinical Practice and research integrity including the development of standards and metrics to measure and monitor research practice and performance. This position participates in assessment of the capabilities of affiliate sites to implement clinical research, routinely reviews clinical trials to determine appropriateness for member institutions and assists in the development of strategic research goals for each program. Further, the Director collaborates with other DCN leaders and DNS colleagues to assess, provide, and address educational needs for affiliated site staff.

Job Qualifications:  Research professional responsible for effective and efficient clinical research operations provided in Duke affiliated oncology programs and other Network Service research activities and the establishment of systems to improve and enhance research related activities affecting patient care.

This is achieved through:

• The development and implementation of research tools and programmatic strategies to ensure the DUHS quality standards for research practices are met at affiliated sites.
• The coordination of clinical trials at affiliated sites
• Evaluation of clinical research competencies, policies, and processes among DCN research staff and at affiliated sites
• Effective relationship building and collaboration with all parties involved in the administration of Duke-affiliated research programs.
• Collaboration with Network Services and DCN administrative, medical, and clinical nursing leadership
• Coordination of DCN research activities in compliance with contract terms of each affiliated program
• Consultative support, as well as logistical support for network activities that require research engagement, e.g., PI-CME.

This position requires the individual to have the ability to respond appropriately in public environments, both on and remote to the Duke campus in high pressure situations. A professional with experience at Duke Medicine or another academic-based health care delivery system with knowledge of research standards and familiarity with community hospital research is preferred. The position interacts with research staff, physicians, and administrative leadership in affiliated hospitals in support of Duke-affiliated research programs. This person represents the interests of the Duke Cancer Network and the Duke Cancer Institute research on committees, teams, and other public forums, as well as liaisons with other Network Service disciplines engaged in research functions. This position is expected to function within the policies and procedures of the Duke University Health System, Duke Cancer Institute, cooperative research groups such as ALLIANCE, as well as local and federal regulations related to clinical research.

Job Duties 

The following description of job responsibilities and standards reflects the major duties of the job but does not describe minor duties or other responsibilities that are assigned from time to time.

Internal Quality and Business/ Patient Safety

Implements and oversees clinical research programs at Duke-affiliated sites

• Collaborates in assessment of affiliated sites' capability to implement clinical research programs
• Ensure site self-monitoring is adequate to assess the appropriateness of management of key clinical trial components and compliance with the protocol and regulatory requirements
• Performs or oversees study-specific monitoring of external sites by DCN or designee to ensure appropriate management of key clinical trial components. This includes investigational agent handling and documentation, timely and accurate data submission, regulatory compliance, and patient care.
• Oversees the completion of a written report to address monitoring findings, including corrective action plan execution by affiliate site
• Collaborates with Duke Investigators to support development of clinical trials for execution at affiliated sites.
• Participates in the ongoing evaluation of clinical trials to determine appropriateness for affiliated sites and assures that reviews of clinical trial appropriateness is ongoing, occurring at each affiliated site on regular basis.
• Monitors affiliated sites to ensure faculty, administration, and staff meet educational and regulatory requirements for participation in clinical research.
• Participates in the development of contracts and budgets for Duke investigator initiated and pharmaceutical company sponsored clinical trials.
• Participates in interdisciplinary quality improvement and/or research quality assurance activities.
• Participates in the ongoing preparation and monitoring of quality assurance programs associated with clinical research and professional educational programs.
• Maintains working knowledge of NCTN cooperative group studies and structure.
• Oversees operation and quality assurance of clinical research programs at affiliate sites through research programs at affiliate sites in collaboration with DCI and staff from the individual cooperative research groups, as appropriate.
• Ensures that affiliated sites who are member institutions under the umbrella of Duke are notified and complete review of new studies, as well as amendments and closures of existing clinical trials.
• Shares best practices for screening and enrollment strategies with the affiliated sites and DCN research nursing staff.
• Ensures DCN research practices and policies are consistent with Duke University and Duke University Health System practices and policies, where appropriate
• Participates/leads efforts to develop policies and procedures and mechanisms for implementation/enforcement of clinical trials in all affiliated sites.
• Collaborates with DCI and DHN to ensure consistency in practice and leverage expertise.
• Reports to DCN and DNS leadership on metrics related to the above activities.

Customer Service and Affiliate Relationships 

• Develops, collaborates and maintains positive relationships with all parties involved in the functioning of Duke-affiliated oncology programs, including, but not limited to staff and physicians of: Duke Cancer Network, entities within the Duke Cancer Institute, Duke research endeavor, Duke CME office, Duke University Hospital, DHIP, affiliate hospitals, and local nursing and medical staff.
• Collaborates with non-oncology Network Service teams in the development of research strategy and provides guidance in the development of non-cancer research program services.
• Develops and implements strategies to build relationships with key members of the affiliate research team and affiliate leadership.
• Develops and maintains work plans for each site to address clinical research program needs and ensures implementation and completion of required action items.
• Creates programmatic strategy to engage Duke investigators in order to facilitate exportation of Duke research into the affiliate community.
• Facilitates efforts to build relationships between Duke and affiliate site investigators to enhance clinical research programs.

• Ensures appropriate network participation on Duke related research and CME programming efforts.
• Ensure research program satisfaction survey results are evaluated and enhanced on an annual basis.

Strategic Development, Finance and Growth 

• Provides input into Duke Cancer Network strategic planning initiatives related to clinical research and professional research education.
• Provides guidance to other Network Service disciplines in development of clinical research strategy and services.
• Creates tools and processes to encourage and support the participation of Duke investigators, including those within DCN, in clinical research, facilitating knowledge of
• Leads efforts for new site assessments related to the research program and develops site specific programmatic strategy and implementation plans.
• Develops and monitors research program budgets, ensuring all services and activities are budgeted and contract work is reconciled.
• Appropriately utilizes resources and is compliant with grant management rules as well as DUHS financial processes.
• Establish procedures around clinical research billing and develop strategies to enhance compliance with research billing regulations.
• Serves as a resource for affiliates on issues related to clinical trial infrastructure, including, but not limited to, billing and reimbursement.
• Participates in strategies to evaluate billing compliance at affiliate programs.
• Develops and oversees individual protocol budgets, and budget functions related to cooperative group research, Duke investigator initiated and pharmaceutical trials.
• Regularly assesses DCN clinical trial financial process assuring accuracy is maintained per protocol.
• Ensures approach to program and protocol management is efficient, streamlined, and strategically meets essential needs of the program.
• Evaluates and regularly assesses meaningful use of technology and research software offerings.
• Reports on strategic and financial metrics to DCN leadership

Work Culture

Performs staff oversight and education functions (inclusive of DCN staff)

• Assists in the development of position descriptions for clinical research staff.
• Assists in recruitment, hiring, and orientation activities for staff.
• Has direct management responsibility for DCN research staff members.
• Performs mid-year and annual reviews for direct report staff, and ensures performance reviews are completed timely for all research team members,
• Fosters a supportive team environment and growth of all members of the research team.
• Participates in employee rounding and employee engagement activities.
• Provides access to developmental/educational/training opportunities for staff including mentoring, competencies assessment and development.
• Assures an annual assessment of continuing education needs at affiliate sites in relation to clinical research and develops and coordinates educational events.
• Oversees the implementation of research educational events to address knowledge gaps. These events may be live local and regional symposium, or via video/web conferencing.

• Participates in cooperative group meetings and annual conferences to further knowledge and keep abreast of trends in clinical research.
• Seeks opportunities for professional grow, expand professional competency, and maintain licensure/certifications, where applicable

Minimum Qualifications 

Education:

• Position requires analytical, organizational and communications skills generally acquired through completion of a bachelor's degree program. Master of Health Care Administration, Post-graduate education in nursing, pharmacy, or research related field, very strongly preferred. Doctoral preparation preferred.

Experience:

• Work requires a minimum of five years progressive management experience within the healthcare industry. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
• Minimum of 6 years of experience as a registered nurse, physician assistant, pharmacist or research professional required with experience in oncology clinical research is strongly preferred.

Degree, Licensure, and/or Certification 

• Certification/license to practice (i.e., as a Registered Nurse/pharmacist in North Carolina) is very strongly preferred. If not currently licensed, must be eligible for licensure/certification, other certifications as appropriate.

Physical and Mental requirements 

• Exposure to hazardous waste and infectious materials
• Physical abilities to complete job duties under prescribed environmental and working conditions
• Ability to travel to affiliated sites, regional and national travel expected (Expected travel includes commercial flights and drive times of 4-6 hours by car.)

Duke is an Affirmative Action/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, sex, sexual orientation, or veteran 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 essentialjob 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.

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