Job Information
University of North Carolina- Chapel Hill Research Regulatory Manager in NC-Chapel-Hill, United States
Employment Type: Permanent Staff (EHRA NF)
Vacancy ID: NF0008269
Salary Range: Salary commensurate with experience.
Position Summary/Description:
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.
Education 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.
Essential Skills:
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
AA/EEO Statement:
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.