REGULATORY COORD - Brain Tumor Clinical Research

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.
Occupational Summary

Perform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including for the Duke Cancer Institute's [DCI] Brain Tumor Center [BTC] Clinical Research Program. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.

Work Performed

Operations, Study and Site Management

Develop and submit Institutional Review Board [IRB] documents such as consent forms, protocols, and continuing reviews, memos to file, and supporting documents. Maintain study level documentation including regulatory binders and e-binders. Submit initial new studies, amendments, continuing reviews, deviations, and safety reports.

Maintain study compliance according to institutional requirements, protocols, and other applicable policies such as NIH Public Access policy, ClinicalTrials.gov, and Research Data Security Plans.

Oversee maintenance of Delegation of Authority Logs, training of key personnel on study-specific duties, financial disclosure forms, FDA Forms, and other regulatory documentation.

Potentially, submit and maintain Investigational New Drug applications (IND).

Work closely with study sponsors and internal committees and offices 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 federal, institutional, and sponsor-specific reporting requirements [timelines and forms].

Communication

Collaborate and communicate with sponsors, study personnel, institutional boards and committees such as the IRB and Cancer Protocol Committee 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.

Leadership

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.

Serve as an expert resource for colleagues and teammates. Support colleagues in their project work; encourage completion.

Ethics

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, and education. Must have strong organizational skills, move from between multiple projects, effectively prioritize competing projects, and have solid written communication skills. The ability to learn new software, such as iMedris, OnCore, and Forte eResearch quickly.

Minimum Qualifications

Education

Completion of an Associate's degree

Experience

Work requires a minimum of two 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.