Regulatory Affairs Specialist I - Remote US
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 Clinical Regulatory Affairs Specialist I primary responsibilities include managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. This position will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines. The Regulatory Affairs Specialist I will maintain a full study workload with minimal supervision. This position is a US-based, full time, fully remote position; relocation assistance and sponsorship are not available.
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
Requirements
- Associate's Degree or higher is preferred, high school graduation diploma required - qualified experience may be substituted for education
- 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