Assistant Research Practice Manager, Duke Cancer Institute

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

 

 

Oncology Clinical Research Unit

 Assistant Research Practice Manager 

 

 

Position Description, 

Occupational Summary

As an Assistant Research Practice Manager [ARPM] in the Duke Cancer Institute [DCI], provide upper level leadership and day-to-day management for assigned teams.  Oversee all aspects of clinical trial management, including site management, data entry and regulatory compliance.  Ensure research is timely and compliant including federal, state, sponsor and institutional policies.  Provide strategic direction and a vision for success. 

Work Performed

Leadership – 30% Effort

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.  Monitor team performance, encourage staff to be continuous learners and seek out, listen to and accept feedback. 

Oversee the fair and consistent application of human resource policies, promptly address problems, and partner with the DCI Human Resource team to manage your teams effectively.  Ensure staff are current with their required licenses and training.  Cross-train and reassign staff as needed.  Foster and encourage the professional development and training of staff: mentor and coach staff.  Be available on a routine basis to provide leadership and facilitate effective teamwork. 

Establish regular communication methods and meetings to manage the research portfolio, ensure compliance, and develop future research projects effectively including staff, Principal Investigators [PI], the DCI Finance Team, leadership, boards and others. 

Maintain close collaborative working relationships with staff, colleagues and collaborators throughout the institution to ensure research comply with Duke Policies and Standard Operating Procedures [SOPs].   

Ensure the conduct of studies is continuous, patients receive the best treatment, and research is in accordance with Duke Policies and Standard Operating Procedures [SOPs].

Financial Management – 25% Effort

Apply knowledge of clinical trials management by developing and refining short and long-term financial goals for the research portfolio.  Develop budget proposals and address budget-related issues in collaboration with the DCI Finance team, Duke Office of Clinical Research [DOCR] PIs, staff, colleagues and regulatory bodies.  Ensure staff effort allocated appropriately.  Review finances to ensure financial objectives are met and compliant with policy.  Recommend corrections as needed.  Be knowledgeable of funding sources including industry, federal and foundation grants. 

Study Conduct – 20% Effort

Manage and solve the issues that arise during the conduct of clinical research.  Support new and current research with creative strategies, monitor documentation and regulatory practices, and quality assurance reviews. 

Serve as an expert resource on the conduct of research.  Identify subject recruitment barriers and develop solutions.  Implement solutions to clinical, logistical, financial and regulatory issues.  Collaborate closely with PIs to develop clinical research plans and protocols, interpret research results and prepare manuscripts for publication. 

Regulatory – 10% Effort

Ensure studies are compliant with the regulatory and documentation requirements of the School of Medicine [SOM], the Institutional Review Board [IRB], DOCR, the institution, sponsors, the FDA, and other groups. 

Ensure studies meet quality assurance standards and audits comply with policy.  Review and respond to audit reports, develop and implement corrective