Research Regulatory Manager

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.

Primary Purpose of Organizational Unit

The UNC Lineberger Comprehensive Cancer Center, founded in 1975, is one of 47 National Cancer Institute (NCI)- designated comprehensive cancer centers in the country. The Center's mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach.

UNC Lineberger's Clinical Protocol Office (CPO) is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The Protocol Office 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 Protocol Office 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.

Position Summary

Under the guidance of the Assistant Director, Regulatory Affairs & Quality Assurance, the Clinical Research Regulatory Manager oversees operations for the UNC Lineberger (LCCC) Clinical Protocol Office (CPO). Serves as a key member of the leadership team with a primary focus on management of regulatory personnel, operational and strategic planning, and implementation of policies and systems. Partners closely with physician leadership to help advance research by facilitating clinical trial activation and execution.

Partners with UNC Institutional Review Board, and IND Specialist to ensure accurate reporting. Performs duties independently and initiates judgement in handling a variety of management issues.

Minimum Education and Experience Requirements

Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity, will accept a relevant Bachelor's degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution. May require terminal degree and licensure.

Required Qualifications, Competencies, and Experience

Knowledge of clinical research principles as defined by Code of Federal Regulations, Good Clinical Practices (GCP) and HIPAA regulations pertinent to research. Knowledge of clinical research and human subjects' protections methodology and technology.

Demonstrated ability to establish goals and objectives; plan and review the work of others and oversee work assignments. Demonstrated ability to take a leadership role in implementing changes in design of clinical research management. Demonstrated ability to problem-solve and resolve quality control issues by changing processes. Demonstrated ability to lead, consult and make recommendations using effective oral and written communications

Preferred Qualifications, Competencies, and Experience

Two years of management experience in a research environment is preferred, or commensurate experience serving in a leadership role within a team. Strong leadership, team building, and problem-solving skills as well as demonstrated ability to work collaboratively with multiple disciplines, i.e. physician, administrative and allied health staff.

CCRP, CCRC, CIRB or RAC Certification preferred. Supervisory experience preferred.

Special Physical/Mental Requirements Campus Security Authority Responsibilities

Not Applicable.

Special Instructions Quick Link https://unc.peopleadmin.com/postings/283078