Regulatory Coordinator

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.

Occupational Summary

Preform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] Melanoma Clinical Research Program [MEL].  The Oncology Clinical Research Unit [CRU] oversees the conduct of research. 

Work Preformed

Operations, Study and Site Management – 40% Effort

• Develop and submit Institutional Review Board [IRB] documents such as consent forms, protocols, and continuing reviews.  Maintain study level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.  Provide regulatory and safety reports.  

• Maintain study compliance according to institutional requirements, protocols and other applicable policies such as NIH Public Access policy, ct.gov, and Research Data Security Plans.  

• Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.

• Work closely with study sponsors on regulatory and safety issues.

• Prepare for study monitoring and study audit visits.  Assist with addressing and correcting findings from study monitoring and study audit visits.

• Complete and submit Adverse Events Reports, according to institution and sponsor-specific reporting requirements [timelines and forms].

Communication – 20% Effort

Collaborate, and communicate with other study personnel as required.  Communicate concerns clearly in a professional manner.  Respond timely to emails, phone calls and questions.  Refer more complex questions and escalate issues to others as appropriate. 

Data – 5% Effort

Use Electronic Data Capture (EDC) systems and enter data accurately.  Review study specific data listings and reports for quality and accuracy.

Leadership – 5% Effort

• Actively network.  Provide leadership within the team.  Actively and proactively participate in team meetings, committees, task forces and ad hoc groups. 

• Encourage career development by actively seeking out continuing education opportunities.  Participate in scientific presentations and publications. 

• Serve as an expert resource for colleagues and teammates.  Mentor staff, including those in the same job title.  Support colleagues in their project work; encourage completion. 

Ethics – 30% Effort

• Summarize and clarify for study teams, the professional guidelines and code of ethics related to regulatory and safety issues in 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.

And other work as assigned. The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.  Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Minimum Qualifications

Education/Training

Completion of an Associate degree.

Experience

Work requires a minimum of two years of research and/or regulatory experience.  A Bachelor's degree may substitute for 2 years of required experience.

Skills

Can easily use computing software and web-based applications [e.g., Microsoft Office products and the electronic medical record].

Preferences

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

Job Code: 00001219 REGULATORY COORD
Job Level: 52

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