[Hiring] Manager of Regulatory Affairs @Sarah Cannon Research Institute

Role Description

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 outside entities.

This is a remote position based in the US; relocation assistance and visa sponsorship are not available.

• 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.

Qualifications

• 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

• Comprehensive benefits to support physical, mental, and financial well-being.
• Competitive compensation package determined by performance, experience, skills, equity, regular job market evaluations, and geographical markets.
• Other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Company Description

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.