REGULATORY COORD, SR
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.
Lead the day-to-dayregulatory and safety operations of a regulato ry team conducting for multiple, complex oncologyclinical t rials and research studies including Investigational Products [IP] forth e Duke Cancer Institute’s [DCI] Center for Immunotherapy Team [CCI].The Oncology Clinical Research Unit [CRU] overseesthe conduct of research.
Work Preformed strong>
Operations, Study and Site Management – 6 0% Effort
Oversee thedevelo pment and submission of documents such asconsent forms, protocols, andc ontinuing reviews to the Institutional Review Board [IRB]. Oversee the maintenance of study level documentationincluding regulator y binders, enrollment logs, patient registration in thesystem of record, etc. Provideregulatory and safety reports.
Oversee study complianceaccording to institut ional requirements, protocols and other applicable policiessuch as NIH P ublic Access policy, ct.gov, and Research Data Security Plans. span>
Oversee maintenanceof Delegation of Auth ority Logs and training of key personnel on study specificduties.
Work closely with study sponsors onregu latory and safety issues.
Oversee preparationf or study monitoring and study audit visits. Address and co rrect findings from studymonitoring and study audit visits.
Oversee thecompletion and submission of Adverse Events Rep orts, according to institutionand sponsor reporting requirements [timeli nes and forms].
Communication – 5 % Effor t
Collaborate,and communicate with other study personnel and colleagues.Communicate concerns clear ly in aprofessional manner.Respond timely toemails, phone calls and questions.Referquestions and escalate issues t oothers as appropriate.
Da ta – 10% Effort
Overseethe Electronic Dat a Capture (EDC) systems and enter ensure data is accurate.Review study data and reports for quality and accuracy.
Leadership –20 % Effort
For assigned staffmanage their day-to-day assignments, work s chedule, work location, approve timeand time off, do their evaluations, and performance management.the DCI’s core value “Cancer C are as ItShould Be” for staff.Create a teamculture that f osters open communication, motivates staff, and encouragescreativity.Seek out, listen to, acceptand act on feedback. Establish regularcommunication methods and meetings with staff; collectively andindividually.Be available to staff on aroutine basis to provide leadership and mentoring.
Provide staff withclear measureable goals, monitor performan ce and quality of work.Assign staff duties and responsi bilities;cross-train and reassign as needed to effectively conduct clini cal research.Foster and encourage the professionaldevelop ment of staff.Oversee stafftraining and certifications toensure compliance with standard operatingprocedures [SOPs], regulations and protocol requirements thatgovern clinicalresearch.< /span>
Serve as an expertresource for colleagues and teammates. Support colleagues in their project work; encour age completion.
Ethics – 5% Effort
Summarizeand clarify for study te ams, the professional guidelines and code of ethicsrelated to regulatory andsafety issues in the conduct of clinicalresearch.
Knowand follow policies, standard operating proc edures (SOPs), regulations andprotocol requirements that govern clinical research.Maintain Duke and project specific trainingand certification requirements.
And other work as assigned.
Completion of an Associate's degree
Work requires a minimum of six years of research and/or regulatory experience. experience. A Bachelor's degree may substitute for 2 years of required
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