Manager, Regulatory Support
Core
Manages clinical studies and regulatory compliance for human subject protocols at an academic medical center, overseeing a team of clinical research monitors and vendor oversight.
Role type
Manager, Regulatory Support
Builds
Clinical study operations and regulatory compliance frameworks
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
Team leadership, operational management, financial oversight, technical proficiency, communication
Preferred skills
None stated
Technologies
Office software, database systems
Responsibilities
Oversees a team of clinical research monitors for investigational site monitoring; identifies study issues and implements solutions; anticipates data needs and implements tools for effective study management; facilitates development of site training documentation and policy manuals; contributes to development of clinical protocols and case report forms; evaluates quality and completeness of data and participant safety documentation; generates monitoring reports and tracks corrections to resolution; provides expert consultation on quality control and regulatory issues; conducts internal and external audit preparations; maintains RSQA related databases and audit files; establishes and assesses effectiveness of internal controls.
Seniority
Manager, hands-on IC