Regulatory Coordinator

Be You.

Perform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] Genitourinary Clinical Research Program [TNA].  The Oncology Clinical Research Unit [CRU] oversees the conduct of research. 

Minimum Qualifications

Education

Completion of an Associate's degree

Experience

Work requires a minimum of two years of research or regulatory experience. Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience.

Preferences

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

Be Bold.

Key Responsiblities

Operations, Study and Site Management – 40% Effort

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

Maintain 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.

Prepare for study monitoring and study audit visits.  Assist with addressing and correcting findings from study monitoring and study audit visits.

Complete and submit Adverse Events Reports, according to institution and sponsor-specific reporting requirements [timelines and forms].

Communication – 25% Effort

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

Data – 5% Effort

Use Electronic Data Capture (EDC) systems and enter data accurately.  Review study specific data listings and reports for quality and accuracy.

Leadership – 10% Effort

Actively network.  Provide leadership within the team.  Actively and proactively participate in team meetings, committees, task forces and ad hoc groups. 

Encourage career development by actively seeking continuing education opportunities.  Participate in scientific presentations and publications. 

Serve as an expert resource for colleagues and teammates.  Mentor staff, including those in the same job title.  Support colleagues in their project work; encourage project 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.

Other work as assigned. 

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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.