Regulatory Assistant

Monday - Friday, 8am-5pm

Flexible work arrangements, including remote/hybrid work locations, are an integral part of the School of Medicine's Working Forward initiative. As such, this position's work location is designated as virtual. Please note that the designated work location is subject to change based on the unit's business needs.

To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.

University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education and research.

Patient care: We promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.

Education: We prepare tomorrow`s healthcare professionals and biomedical researchers from all backgrounds by facilitating learning within innovative and integrated curricula and team-oriented interprofessional education to ensure a highly skilled workforce.

Research: We develop and support a rich array of outstanding health sciences research programs, centers and resources. We provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our university to support outstanding research. We foster programs in the areas of basic, translational, mechanistic and population research.

The purpose of this position is to facilitate the conduct of oncology clinical trials by providing regulatory document support to ensure compliance with federal regulations, Good Clinical Practice, and local and institutional policies. In particular, this position is responsible for:

Regulatory Essential Document Collection and Regulatory Binder Maintenance

* Preparing, collecting, and obtaining signatures for essential documents for electronic regulatory binder, including delegation of authority/delegation of task log, financial disclosure forms, Form FDA 1572, training documentation, protocol signature page, IB acknowledgments, lab certifications, medical licenses, CVs
* Maintaining regulatory binder, including naming regulatory documents in accordance with defined nomenclature, filing regulatory documents in eRegulatory binder in accordance with defined filing structure
* Communicating with sponsors and monitors regarding status of essential regulatory documents and providing essential documents as required
* Tracking and recording pending regulatory actions through completion on study team trackers
* Providing updates on status of pending regulatory actions at study team meetings (oral and/or written) and takes meeting minutes
* Accurately entering IRB approval information into the electronic clinical research management system (OnCore) and uploading study documents into OnCore within required deadlines
* Other duties as assigned

Monitoring and Auditing Compliance
* Preparing regulatory binder for monitoring and audit visits and addresses regulatory findings within required deadlines.

Portfolio Management: Regulatory IRB Applications
* Preparing, submitting, and processing in a timely and accurate manner IRB applications for:
o continuing reviews for closed to accrual studies with all patients off treatment to the IRB of record
o personnel modifications to UNC IRB
o external IND safety reports to UNC IRB

This position may include involvement in process improvements:
* Developing, writing and providing input on standard operating procedures, work instructions, and internal processes.
* Mentoring new Regulatory team members
* Participating on CTO committees/task forces/working groups
* Assisting in training Regulatory team members as needed
* Attending pre-study team regulatory meetings for assigned study teams

These responsibilities relate to the UNC/ LCCC Clinical Research mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.

Bachelor's degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

High level of accuracy and attention to detail.
Solid writing skills.
Demonstrated ability to organize and present information.
Demonstrated ability to plan work to meet objectives and deadlines.
Demonstrated ability to communicate effectively and professionally verbally and in writing.
Strong computer skills, including working knowledge and facility with Outlook, Word, Excel, and PowerPoint.
Ability to work on evenings, weekends and/or holidays occasionally required.
A cover letter is required as an example of professional written communication skills.

Experience in regulatory binder maintenance for FDA-regulated clinical research studies.
Experience in clinical research, including knowledge of 21 CFR Parts 50, 54, 56, 312, 314, 812 and ICH GCP Guidelines.
Experience using an eRegulatory system (such as Florence) and a clinical trials management system (such as OnCore).

Requires sitting for extended periods of time.

Not Applicable.

If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to employment@unc.edu

Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.