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

Lead the day-to-day operations of a coordination team conducting multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute's [DCI] Bone Marrow Transplant, Hematology Malignancies & Cellular Therapy Clinical Research Programs [BMT]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.

Work Preformed

Operations, Study and Site Management - 35% Effort

Work closely with the Principal Investigator [PI] to recruit, screen and enroll participants for studies. Implement strategies to maintain recruitment and retention rates, and assist participants with individual needs. Design and implement information collection to determine appropriate study feasibility, recruitment and retention strategies. Evaluate processes to identify issues related to recruitment and retention rates; offer solutions.

Lead coordination activities to successfully implement and conduct the study. Recognize and offer solutions to study problems. Assist in the development of new studies. Lead the development of Conflict of Interest [COI], Data Safety Monitoring Plans [DSMPs], and Research Data Security Plans [RDSPs].

Oversee study compliance with institutional requirements and policies; maintenance of appropriate study-level documentation including regulatory binders, enrollment logs, and patient registration in the system of record; adverse events [AE] recording and reporting. Oversee Delegation of Authority Logs and training of key personnel on study specific duties.

Lead procedures to document study payment and participant care expenses in a timely fashion. Monitor financial study milestones and report appropriately. Coordinate with financial teams and participate in budget development. Assist with study budgets and closeouts.

Communication - 20% Effort

Serve as primary liaison with sponsors, study personnel and PI for assigned studies. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions.

Data - 15% Effort

Implement Electronic Data Capture [EDC] systems to accurately enter. Detect issues related to data capture, collection or management and suggest solutions.

Find vulnerabilities related to security of physical and electronic data and investigate incomplete, inaccurate or missing data and documents; offer solutions.

Leadership - 20% Effort

Lead, supervise and manage assigned staff including coaching, time-off, annual performance review, performance management, career development, and training. 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.

Serve as an expert resource for colleagues and teammates. Support colleagues in their project work; encourage completion.

Ethics - 10% Effort

Communicate to study staff and research participants the difference between clinical and research activities, and the risks and benefits of study participations. Recognize when staff and patients are having difficulty with the distinction and work hard to help them understand the differences. Summarize and clarify for study teams, 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.

Other work as assigned.

Basic Life Saving [BLS] certification from the American Heart Association or Duke approved equivalent course is a requirement of this position.

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 an Associate degree.

Experience

Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required 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 oncology or research experience, training, education or clinical trials coordination 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.