Regulatory Coordinator, Senior

Regulatory Coordinator, Senior

Work Arrangement: Remote Requisition Number: 247416 Regular or Temporary: Regular Location:

Durham, NC, US, 27710

Personnel Area: MEDICAL CENTER Date: Jul 3, 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 2,600 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

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] Bone Marrow Transplant Hematology Malignancies & Cellular Therapy Clinical Research Program [BMT]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.

Work Performed

Operations, Study and Site Management – 40% Effort

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Participates in or leads development of monitoring and audit training sessions and/or policies and guidelines for research program. Serves as an expert resource to address and correct findings. Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training and lends expertise to multiple study teams. Prepares for and leads effective facilitation of research program meetings in order to achieve objectives. Ensures good communication within the research program, including mentoring staff to improve communication strategies.

Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits. Oversees use of systems and system reports to manage research protocol activities and maintaining current protocol information. Oversees management of resources (staff, supplies, equipment) for multiple study teams/research program. May manage the budget for research studies. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies. Oversees implementation of operational plans across multiple study teams or sites. Develops and implements closeout procedures for multiple studies across multiple teams.

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 – 10% 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.

Leadership – 40% Effort

Encourages staff to take part in professional development opportunities. Keeps current with advances in the scientific area and considers the impact on the research program. Keeps self and team current with research updates by attending external offerings; applies learned material on the job. Plays key/leadership role on committees and workgroups. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Develops and implements solutions that work within the existing leadership or organizational structure. Demonstrates resilience and actively facilitates the research program through change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation within the research program. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns the activities of the research program team members to accomplish the study goals.

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 – 10% Effort

Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review. Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.

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.

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.

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

Preferences

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

Job Code: 00001220 REGULATORY COORD, SR
Job Level: 53

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.

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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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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