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 [CRU]

Bone Marrow Transplant, Hematology Malignancies &

Cellular Therapy Clinical Research Programs [BMT]

Occupational Summary

Provide leadership in the development, implementation and management of research for the Duke Cancer Institute’s [DCI] Bone Marrow Transplant, Hematology Malignancies & Cellular Therapy Clinical Research Programs [BMT]; the Oncology Clinical Research Unit [CRU] provides research oversight. Serve as the primary liaison throughout the institution for assigned projects. Responsible for managing projects through the entire lifecycle, from concept to initiation to closeout: responsible for project results including costs and reporting.

Work Preformed

Program, Project and Study Management – 50% Effort

Work closely with the Principal Investigator [PI] and research team on goals, study feasibility, design, protocols, resources, and recruitment and retention strategies. Evaluate plans, processes and results to make recommendations for improvement; develop and implement solutions. Contribute expertise in research design to develop protocol and research proposals. Evaluate and include cultural diversity and competency in study design and conduct.

Assist with budget development; monitor and adhere to the established budget.

Participate in, and provide oversight, including communication, for IRB submissions and documentation, regulatory and safety reporting, and adverse events. Coordinate Duke core services such as Investigational Drug Service [IDS] and Biobank, as applicable. Be familiar with intellectual property rights, inventions patents, and technologies. Understand regulations related to investigational products with sponsors. Manage agreements such as Material Transfer and Investigational New Drug Applications.

Assist with the development, selection, and implementation of data capture methods and protocol-specific systems and documents. Oversee the design of data forms such as; electronic case reporting forms [ECRF], electronic data capture [EDC], data flow, queries, quality assurance, and data security. Develop safety and security documents such as research data storage plans [RDSP], conflict of interest [COI], and data safety management plans [DSMP].

Science – 10% Effort

Collaborate with stakeholders [statistical, operational, etc.] to ensure adequate design, implementation and testing of study aims. Develop research proposals or protocols with little assistance. Summarize study results.

Contribute significant writing and editing to grant and funding proposals and the development of investigator-initiated studies. Read and analyze literature to assist with manuscripts. Keep current on scientific advances.

Communication – 10% Effort

Collaborate, and communicate with PI and study personnel as required. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Escalate issues to others as appropriate.

Leadership – 10% Effort

Serve as an expert resource for colleagues and teammates. Assist colleagues in identifying efficiencies and improving process. Support colleagues in their project work; encourage completion. Actively network.

Provide leadership within the team. Mentor staff. Prepare for, lead and participate in team meetings, committees, task forces and ad hoc groups.

Supervisory – 10% Effort

Lead and supervise staff. Manage their day-to-day work assignments, work location, approve time off, annual evaluations, performance, and career development. Work closely with DCI HR.

Model the DCI’s core value “Cancer Care as It Should Be” for staff. Create a team culture that fosters open communication, motivates staff, and encourages creativity. Seek out, listen to, accept and act on feedback. Establish regular communication methods and meetings with staff, collectively and individually. Be available to staff on a routine basis to provide leadership and mentoring.

Provide staff with clear measureable goals, monitor performance and quality of work. Assign staff duties and responsibilities; cross-train and reassign as needed to effectively conduct clinical research. Foster and encourage the professional development of staff. Oversee staff training and certifications to ensure compliance with standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research.

Ethics – 10% Effort

Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. 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.

Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. Articulate, to study staff and research participants, the reasoning for an individual protocol's inclusion and exclusion criteria. Provide departmental-wide training in the ethical conduct of research. Serve as an expert resource in study design to ensure inclusion of safeguards, protection of vulnerable populations and ethical conduct standards.

Other work as assigned.

Skills

Knowledge of therapeutic research design. Ability to effectively collaborate and communicate with diverse communities to move projects forward.

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.

Qualifications Required At This Level

Education/Training

Completion of a Bachelor's degree.

Experience

Work requires a minimum of four years of research experience (e.g., research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related experience.

Skills

Can easily use computing software and web-based applications [e.g., Microsoft Office products and internet browsers].

Preferences

The preferred candidate will have experience in research and medical writing.

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.