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Role Description

Our Clinical Regulatory Affairs Specialist II 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.

• 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

Qualifications

• Associate's Degree or higher is preferred, high school graduation diploma required - qualified experience may be substituted for education
• 3+ years' regulatory affairs work experience in a clinical research, pharmaceutical, site management organization highly desired
• Knowledge of medical terminology, FDA, other regulatory processes highly preferred

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 750 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 today. SCRI’s research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S.