REGULATORY COORD

Job description

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.

Oncology Clinical Research Unit [CRU]

National Clinical Trials Network Clinical Research Program [NCTN]

Occupational Summary

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

Work Preformed

Operations, Study and Site Management – 65% 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 – 15% 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 – 5% 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 out 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 completion.

Ethics – 10% 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

IRB submission, IRIS (Duke system)
oncology research experience
computer database

Qualifications Required At This Level

Education/Training

Completion of an Associate degree.

Experience

Work requires a minimum of two years of research and/or regulatory experience. A Bachelor's degree may substitute for 2 years of required experience.

Skills

Can easily use computing software and web-based applications [e.g., Microsoft Office products and the electronic medical record].

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.

 

 

 

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Job No:
Posted: 1/9/2021
Application Due: 3/10/2021
Work Type: Full Time
Salary: