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