Regulatory Affairs Specialist I

Sarah Cannon Research Institute•Usa, TN

1d•Remote

About The Position

Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. 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. 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