Regulatory Affairs Specialist I

Sarah Cannon Research Institute

1d • Remote

About The Position

Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is a leading oncology research organization focused on advancing therapies for cancer patients. SCRI conducts community-based clinical trials and has been a leader in drug development for over three decades, contributing to pivotal research that led to the majority of new cancer therapies approved by the FDA in the past decade. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country, bringing together over 1,300 physicians and enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. McKesson, the parent company, delivers products to healthcare providers, making a difference in patient care. The mission of SCRI is centered on people who live with cancer, aiming to prevent, fight, and survive it, by bringing innovative medical minds and passionate caregivers together to transform care and personalize treatment through clinical excellence and cutting-edge research. The Clinical Regulatory Affairs Specialist I manages and plans regulatory affairs compliance for industry sponsors and/or sites in networks. This role involves working closely with regulatory affairs management, department director, and/or primary investigators to ensure compliance and prepare for auditing activities while meeting strict deadlines. The Regulatory Affairs Specialist I will maintain a full study workload with minimal supervision. This is a US-based, full-time, fully remote position; relocation assistance and sponsorship are not available.

Requirements

• High school graduation diploma required

Nice To Haves

• Associate's Degree or higher is preferred
• 1+ year work experience in a clinical research, pharmaceutical, site management organization highly desired focused in required regulatory affairs
• Knowledge of medical terminology, FDA, other regulatory processes highly preferred

Responsibilities

• Establishes and maintains a document management system for regulatory electronic files
• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
• Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOPs) for format and content
• Maintains critical documentation ensuring compliance
• Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA. This includes time sensitive correspondence with sponsors and other stakeholders.
• Organizes and processes documentation for IRB submission for multiple trials
• Processing of Protocol Deviations that meet the IRB reportable criteria
• Submits urgent safety notifications to the IRB
• Other duties as assigned

Benefits

• Comprehensive benefits to support physical, mental, and financial well-being
• Competitive compensation package (base pay, annual bonus or long-term incentive opportunities)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 1-10 employees