Regulatory Affairs Specialist I

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

1d•Remote

About The Position

The Regulatory Affairs Specialist I is responsible for managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. This position will collaborate closely with regulatory affairs management, the department director, and/or primary investigators to ensure compliance, prepare for auditing activities, and meet strict deadlines. The Regulatory Affairs Specialist I will manage a full study workload with minimal supervision. This position is a US-based, full-time, fully remote role.

Requirements

High school graduation diploma required.
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.

Nice To Haves

Associate's Degree or higher is preferred.
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.
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.