Clinical Research Coordinator, Senior

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Lead the day-to-day operations of a data coordination team conducting multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] GI Research Program [GI].  The Oncology Clinical Research Unit [CRU] oversees the conduct of research. 

Work Preformed

Operations, Study and Site Management –50% 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 – 5% 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 daily work assignments, time-off management, performance review, performance management, career development, training, coaching mentoring, hiring, and terminations.  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 measurable 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 – 5% 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. 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.

Minimum Qualifications

Education

Work requires an Associate's degree. Basic Life Saving [BLS] certification from the American Heart Association or Duke approved equivalent course is a requirement of this position

Experience

Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required experience.

Preferences

The preferred candidate will have oncology or research experience, training, education or clinical trials coordination experience.   

Job Code: 00001202 CLINICAL RESEARCH COORDINATOR, SR
Job Level: 53

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