Clinical Research Regulatory Affairs Manager - Remote US

Sarah Cannon Research Institute

3d • Remote

About The Position

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. Our Regulatory Affairs Manager oversees all aspects of the regulatory operations for Sarah Cannon site Clinical Operations and manages the regulatory department. This position is responsible for developing and implementing short- and long-term strategies for the regulatory compliance for the site Clinical Operations. You will ensure Sarah Cannon adheres to and maintains FDA regulatory compliance as well as oversees any regulatory audit. This position will work closely with the department directors and/or primary investigators, industry sponsors and other outsides entities. This is a remote position based in the US; relocation assistance and visa sponsorship are not available.

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

Responsibilities

• Manages, directs, plans and schedules activities and programs for the regulatory department
• Establishes and enforces procedures that assure all trial teams and sites are fully compliant with all applicable laws, regulations, SOPs, and other applicable guidelines
• Develops and implements regulatory policies and procedures for the sites and the site Clinical Operations team, including managing and planning regulatory affairs compliance for industry sponsors and/or sites
• Manages the regulatory affairs between the organization for multiple clinical trials according to FDA and GCP guidelines; for individual sites, studies, sponsors and/or other networks
• Manages the relationships between industry partners and the FDA regarding regulatory compliance for the organization and managing regulatory audits of studies by sponsor/industry and governmental auditors.
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1-10 employees