Director, Clinical Research
A 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. 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 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.
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 cancer and cardiology 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.
- Collaborates in assessment of affiliated sites’ capability to implement clinical research programs
- Performs on-site monitoring to ensure site is compliant with federal,local, and institutional requirements regarding the conduct of clinical trials
- Performs or oversees study-specific monitoring 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 determine appropriateness of Duke Initiated clinical trials at affiliated sites.
- Participates in the ongoing evaluation of clinical trials to determine appropriateness for affiliated sites
- Assures that reviews of clinical trial appropriateness is occurring at each affiliated site on regular basis
- 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 cooperative group staff and DCN clinical research staff, where appropriate
- Ensures that member institutions are reviewing and being notified of new studies, amendments and closures
- Monitors affiliated sites to ensure faculty, administration, and staff meet educational and regulatory requirements for participation in clinical research
- 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
- 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, Duke Cancer Institute, Duke research endeavor,Duke CME office, Department of Radiation Oncology, Duke University Hospital, PDC, 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
- 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
- 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 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•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
- Provides access to developmental/educational/training opportunities for staff including mentoring,competencies assessment and development
Requisition Number 401451285
Duke Entity HEALTH SYSTEM
Job Code 5226 DIR, NETWORK SERVICES
Job Family Level I2
Full Time / Part Time FULL TIME
Regular / Temporary Regular
Duke University 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 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.
Position requires analytical, organizational and communications skills generally acquired through completion of a bachelor's degree program. Master of Health Care Administration or MBA preferred.
Work requires a minimum of five years management experience within the healthcare industry. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Degrees, Licensures, Certifications (Preferred)
Experience as a registered nurse, physician assistant, pharmacist or research professional in oncology clinical research is strongly preferred. Certification/license or eligible to practice as a Registered Nurse in North Carolina is very strongly preferred.
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