Sarah Cannon Research Institute (SCRI) is looking for a Clinical Regulatory Affairs Specialist II to manage and plan regulatory affairs compliance for industry sponsors and research sites. In this role, you will ensure adherence to local SOPs and prepare for auditing activities while handling a full study workload.
What You'll Do
- Establish and maintain a document management system for regulatory electronic files.
- Maintain FDA and GCP required regulatory documentation for sites, studies, and sponsors, ensuring compliance with local Standard Operating Procedures.
- Modify and develop informed consent forms and manage protocol, investigator drug brochure, and consent form amendments per IRB policy and HIPAA.
- Organize and process documentation for IRB submission for multiple trials.
- Process Protocol Deviations that meet the IRB reportable criteria.
- Submit urgent safety notifications to the IRB.
What We're Looking For
- High school graduation diploma.
Nice to Have
- Associate's Degree or higher.
- 3+ years of regulatory affairs work experience in a clinical research, pharmaceutical, or site management organization.
- Knowledge of medical terminology, FDA, and other regulatory processes.
Team & Environment
Works closely with regulatory affairs management, department director, and/or primary investigators.
Benefits & Compensation
- Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Benefits details are available via our parent company, McKesson.
Work Mode
This is a fully remote position open to candidates within the United States.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
