UNC Lineberger Comprehensive Cancer Center

The Regulatory Manager is responsible for performance management of Clinical Protocol Office ( CPO ) Regulatory Staff. This supervisory role is comprised of staffing, work assignment, implementing the performance management program, supporting staff learning and development, leave management and schedules, and HR-related functions. This position is also responsible for the development and implementation of Regulatory Standard Operating Procedures. These responsibilities relate to the mission of the   UNC / LCCC   Protocol Office by addressing the regulatory compliance, thereby ensuring the quality of research and institutional integrity. Minimum Education and Experience RequirementsRelevant 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 -Supervisory experience