Regulatory Associate Lead

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.

The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing 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. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service.
OUR VISION
Our vision is to be the nation's leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.
OUR MISSION
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 will 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 will prepare tomorrow's health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.
Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.

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

* Assisting Regulatory Management by providing managerial support, including reviewing promptly reportable information reports to the IRB, participating in interviews of Regulatory applicants, monitoring trends in actions items/findings from monitoring letters and audit reports, attending pre-study team regulatory meetings, and signing off on timecards for Regulatory staff
* Taking a lead role in activation of new oncology clinical trials, including preparing and submitting regulatory documents for new studies to the IRB and ancillary committees, as well as monitoring and assisting with activation activities performed by other Regulatory staff
* Assisting with Regulatory training, including drafting standard operating procedures and work instructions, preparing and leading trainings for Regulatory staff, and participating on CTO committee and working groups
* Preparing, submitting, and processing regulatory applications, forms and documents required to conduct clinical research at UNC LCCC to the to the IRB and ancillary committees
* Preparing informed consent forms, HIPAA documents, and participant materials
* Ensuring regulatory compliance for assigned disease groups, including timely and accurate reporting of unanticipated problems and noncompliance events to the IRB, contributing to development of CAPAs and root causes analyses for non-compliance events, and preparing for monitoring and audit visit and responding to action items and findings
* Assisting with the maintenance of the regulatory binder, including entering regulatory and study information in the electronic clinical trial management system (OnCore) and eRegulatory binder (Florence).

These responsibilities relate to the UNC/ LCCC CTO 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 in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Demonstrated experience in clinical research, including advanced knowledge of 21 CFR Parts 50, 54, 56, 312, 314, 812 and ICH GCP Guidelines.
Demonstrated experience using an eRegulatory system
Possess strong decision-making skills and the ability to problem solve and troubleshoot issues
High level of accuracy and attention to detail
Demonstrated experience preparing and submitting accurate and complete IRB submissions, including initial and maintenance submissions, for complex treatment and nontreatment trials.
Demonstrated ability to write standard operating procedures and prepare and lead trainings
Demonstrated experience providing consultation and leading discussions regarding regulatory actions and compliance.
Solid writing skills and experience preparing comprehensive reports
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 sit for extended periods of time.
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 preparing and maintaining IRB applications, including initial, continuing review, amendment modification, and expedited report submissions, for:
- therapeutic clinical research studies involving a drug or device, and/or
- oncology clinical research studies
Experience preparing submissions to ancillary committees, such as the Protocol Review Committee, Institutional Biosafety Committee, Investigational Drug Services, Radiation Safety Subcommittee.
SOCRA, RAC, or ACRP certification preferred
Project management experience

The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.