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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
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
Sarah Cannon Research Institute
Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.