About this role

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.
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.

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.

Comprehensive benefits to support physical, mental, and financial well-being.
Total Rewards offerings serve the different needs of our diverse colleague population.

Regulatory Affairs Specialist I

Key skills