Regulatory Affairs Specialist I
About The Position
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. The 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.
Requirements
- 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
Nice To Haves
- Associate's Degree or higher is preferred
- 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
- annual bonus or long-term incentive opportunities may be offered
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
