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
• 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