Senior Regulatory Coordinator

1 month ago

Durham, United States Duke Health Full time

Senior Regulatory Coordinator

Work Arrangement: Requisition Number: 230973 Regular or Temporary: Regular Location:

Durham, NC, US, 27710

Personnel Area: MEDICAL CENTER Date: May 24, 2024 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. 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.

The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.

Preferences

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

Qualifications Required At This Level

Minimum Qualifications

Education

Completion of an Associate's degree

Experience

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

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.


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh

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