STRATEGIC SERVICES ASSOCIATE, SR
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.
For the Duke Cancer Institute [DCI] support of the National Cancer Institute’s [NCI] Cancer Center Support Grant [CCSG] by overseeing all aspects of the required scientific review, data, safety, and monitoring including management of staff. This position reports to the Associate Director of Compliance and Training.
Responsibilities and Expectations
Develop, coordinate, and implement administrative and operational strategies for scientific review, data and monitoring of oncology clinical research projects. Oversee portfolio management and protocol development including submission, review, and activation for oncology clinical research. Build clinical trial databases and trial tracking to evaluate the merit of oncology clinical research proposals, and to analyze complex datasets.Serve as an expert resource for staff, leadership, and colleagues throughout the institution on study-specific protocol requirements and problem solving for scientific review, data, monitoring, regulatory and safety issues.
Perform gap analyses to identify operational inefficiencies. Identify compliance problems, issues, obstacles, and barriers across oncology clinical trials in relation to safety and monitoring. Communicate patterns and trends to leadership. Develop solutions. Lead the effort to implement process and system improvements and efficiencies.
Provide reports and data to DCI leadership on clinical trial conduct and regulatory compliance issues. Assist DCI leadership in the administration of the CCSG.
ManagementManage and oversee the monitoring of oncology clinical research trials to ensure the quality and integrity of clinical trials conducted through the CRU. Assist in the development and implementation of ONCORE to maximize efficiency, safety reporting and evaluation processes. Maintain and manage the safety reporting processes when ONCORE safety is operational. Manage the entire safety oversight process of oncology clinical trials. Manage and oversee the Safety Oversight Committee [SOC] for the Oncology Clinical Research Unit [OncCRU], including meeting records such as attendance and minutes. Shepherd oncology clinical trials through the SOC process including creating, writing and drafting SOPs. Facilitate the recruitment and membership to the SOC. Manage the entire scientific review process of oncology clinical trials. Manage and oversee the Cancer Protocol Committee [CPC] for the Oncology Clinical Research Unit [CRU], including meeting records such as attendance and minutes. Shepherd oncology clinical trials through the CPC process including creating, writing and drafting SOPs. Facilitate the recruitment and membership to the CPC. Supervisory Embody the DCI’s core value “Cancer Care as It Should Be” to deliver the highest quality care in our patient-centric clinical research, as a leader of research staff and for all of the DCI. Create a culture that fosters open communication, motivates staff, and encourages creativity. For assigned staff manage the day-to-day work assignments, schedule and location, time away, conduct yearly evaluations and goal setting, and actively engage in performance management including corrective action. Implement professional development and training programs to encourage staff retention, continuous improvement, and development. Align team with the workflows, needs and priorities of the DCI and the clinical research community. Oversee the fair and consistent application of human resource policies, and promptly address problems to manage your teams effectively. Collaborate closely with DCI Human Resources on personnel issues; implementing policies, personnel file documentation and compliance. Ensure your managers carry these out appropriately.
And other work as assigned
The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.
The Preferred Candidate Possesses
- At least 3 years oncology clinical research operations experienceExperience with NIH/NCI grant administration (e.g. through prior work responsibilities, successful awarding of an NIH/NCI grant proposal, etc.)Familiarity with the requirements of the CCSG
Qualifications Required At This Level
Work requires a Bachelor's degree.
Work requires a minimum of five years of related business/administration experience: OR an equivalent combination of relevant education and/or experience.
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