Clinical Research Regulatory Affairs Manager

Job Description: • Oversees all aspects of the regulatory operations for Sarah Cannon site Clinical Operations and manages the regulatory department • Responsible for developing and implementing short- and long-term strategies for regulatory compliance • Ensures Sarah Cannon adheres to and maintains FDA regulatory compliance • Oversees any regulatory audit • Works closely with department directors and/or primary investigators, industry sponsors and other outside entities • Manages, directs, plans and schedules activities and programs for the regulatory department • Establishes and enforces procedures for trial teams and sites compliance • Develops and implements regulatory policies and procedures for the site Clinical Operations team • Manages the regulatory affairs for multiple clinical trials according to FDA and GCP guidelines • Manages relationships between industry partners and the FDA regarding regulatory compliance and auditing Requirements: • Bachelor's Degree • 1+ year work experience with 5+ years' preferred in clinical research corporation and regulatory team - education may be substituted for partial experience • Knowledge of scientific and clinical research terminology • Knowledge of FDA and GCP guidelines • Knowledge of organizational policies, procedures, and systems • Advanced skills with MS Office products including Excel, Word, Outlook • Experience meeting strict deadlines and supervising team members Benefits: • Total Rewards package includes comprehensive benefits to support physical, mental, and financial well-being • Competitive compensation package determined by several factors including performance, experience and skills