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.

Oncology Clinical Research Unit [OncCRU]

Position Description

Occupational Summary

Responsible for the oversight of research and day-to-day operations including finances and personnel management for the Bone Marrow Transplant, Hematology Malignancies & Cellular Therapy Clinical Research Programs of the Duke Cancer Institute (DCI). Collaborate closely with DCI Leadership, Finance and Human Resources, Duke Office of Clinical Research [DOCR], School of Medicine [SOM], Principal Investigators [PIs] and departments throughout the institution to carry out these responsibilities effectively.

Work Performed

Research Operations

Oversee study conduct including study initiation, IRB submissions and renewals, protocol initiation, participant recruitment, screening, consent and enrollment, data collection, safety reporting, study monitoring and audits, study closeout, and record retention and storage. Assist with the development of participant recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

Monitor the status of timelines and milestones for research studies to ensure timeliness, performance in accordance with all institutional standards, and compliance with Good Clinical Practice standards, Duke Policies and procedures, SOPs, and applicable regulatory requirements. Provide updates and reports to leadership as required.

Conduct quality assurance audits. Oversee and participate in internal and external audits. Review and implement audit reports; develop and implement corrective actions plans in response to identified problems.

Oversee compliance with institutional requirements pertaining to quality data collection and capture, data flow plans, data security and provenance, and data quality assurance. Connect study teams with stakeholders (e.g., statisticians) and institutional resources (e.g., ISO, IRB) to ensure data quality. Ensure Quality Assurance processes are in place and followed.

Responsible for the implementation, adoption, and monitoring of new research technologies or systems and data capture requirements (e.g. Oncore, Maestro Care, eReg, Advarra EDC etc.).

Financial

Collaborate on writing and implementing contracts and agreements.

Collaborate and work closely with the DCI Finance Team and assigned research programs on the feasibility of new studies including staffing requirements, clinical and logistical considerations, drafting budgets, and budget negotiation and payment terms, maximizing revenue, effort reporting and closing out studies.

Review financial reports to identify and implement solutions to budget-related issues. Bring in DCI leadership, PIs, research staff and others for discussions and solutions.

Manage and approve monthly staff effort in collaboration with the finance team.

Management

Responsible for requesting and managing clinical research system access for staff.

Continuously identify methods to improve CRU and institutional procedures and policies. Base decisions on data analysis collected via clinical research management systems.

Develop strategies to ensure implementation of institutional SOPs, policies, and initiatives.

Oversee the writing, implementation and maintenance of standard operating procedures [SOP] within the DCI CRU. Ensure staff are trained and knowledgeable in SOPs.

Oversee orientation and ongoing training for staff on your teams. Oversee the documentation of staff’s requited training and certifications. Ensure staff identified by the e-IRB system as responsible for a given protocol qualify for the role and maintain their qualification.

Conduct and lead meetings for leadership, teams, and staff to ensure good communication, including goals. Effectively communicate new policies, regulatory updates, and institutional SOP changes.

Leadership

Manage the day-to-day assignments, work schedule, work location, time including time-off, complete yearly evaluations, actively engage in performance management, career development, hire, terminate, and be a mentor and coach for direct reports.

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.

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 and your manager on personnel issues; implementing policies, personnel file documentation and compliance. Ensure your managers carry these out appropriately.

For direct reports manage their day-to-day assignments, work schedule, work location, approve time off requests, conduct yearly evaluations and goal setting, and actively engage in performance management including corrective action.

Serve as an expert resource on study-specific protocol requirements and problem solving for clinical, logistical, financial and regulatory issues.

Implement professional development and training programs to encourage staff retention, continuous improvement, and development (e.g. DOCR: Research Professionals Network (RPN), Research Wednesdays).

Assist in the development and implementation of solutions at the institutional level to improve the research process. Use expertise and acumen to influence change within the DCI. Demonstrate resilience, leadership, and actively facilitate change.

Ethics

Know and follow policies, standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research. Maintain Duke and project specific training and certification requirements.

Other work as assigned.

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.

Work requires completion of a Bachelor'sdegree. ACRP or SOCRA certification preferred.

Work requires a minimum of eight years of related experience, with at least five years in a research setting. A Master's degree may substitute for two years of related experience.

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.