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 Lineberger Comprehensive Cancer Center ( LCCC), founded in 1975, is a designated National Cancer Institute (NCl)-designated comprehensive cancer center. The Center's mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach.

UNC LCCC's Clinical Trials Office ( CTO) is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The CTO provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval and implementation processes of protocols conducted at UNC and its affiliate institutions. The CTO is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large.

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.

At least 2 years of 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
At least 2 years of 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.