Senior 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 2,500 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.

Oncology Clinical Research Unit [CRU]

Brain Tumor Clinical Research Program [btc]

 

1220 Senior Regulatory Coordinator. Sr. [RC Sr.]

 

Position Description, 

Occupational Summary

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

Work Preformed

Operations, Study and Site Management – 35% Effort

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

Oversee 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.

Oversee preparation for study monitoring and study audit visits. Address and correct findings from study monitoring and study audit visits.

Oversee the completion and submission of Adverse Events Reports, according to institution and sponsor-specific reporting requirements [timelines and forms].

Communication – 20% Effort

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

Data – 5% Effort

Oversee the Electronic Data Capture (EDC) systems and enter ensure data is accurate. Review study data and reports for quality and accuracy.

Leadership – 20% Effort

Lead, supervise and manage staff including coaching, time-off, annual performance review, performance management, career development, training, 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 – 20% 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.