Research Regulatory Affairs Specialist

Sarah Cannon Research Institute•Work at Home - Tennessee, USA (WTNA), TN

About The Position

The Research Regulatory Affairs Specialist 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.

Requirements

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
Associate's Degree or higher is preferred, high school graduation diploma required - qualified experience may be substituted for education

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