Senior Regulatory Coordinator

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

Link to view the education, training, experience and skills required for a 1280 Research Program Leader position:  https://forms.hr.duke.edu/descriptions/university/select.php?ID=1220

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

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