Clinical Regulatory Affairs Specialist II
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Job Description
Clinical Regulatory Affairs Specialist managing regulatory compliance for SCRI’s community-based oncology trials. Maintaining FDA, GCP, IRB, and HIPAA documentation remotely across U.S. research networks.
Responsibilities:
- Manage and plan regulatory affairs compliance for industry sponsors and/or sites in networks
- Work closely with regulatory affairs management, department director, and/or primary investigators to ensure compliance
- Prepare for auditing activities while meeting strict deadlines
- Maintain a full study workload with minimal supervision
- Establish and maintain a document management system for regulatory electronic files
- Maintain FDA- and GCP-required regulatory documentation for individual sites, studies, sponsors, and/or other networks
- Ensure regulatory documentation complies with local Standard Operating Procedures (SOPs) for format and content
- Maintain critical documentation ensuring compliance
- Modify and/or develop informed consent forms and manage protocol, investigator drug brochure, and consent form modifications or amendments in compliance with IRB policy and HIPAA
- Manage time-sensitive correspondence with sponsors and other stakeholders
- Organize and process documentation for IRB submission for multiple trials
- Process protocol deviations meeting IRB reportable criteria
- Submit urgent safety notifications to the IRB
- Perform other duties as assigned
Requirements:
- High school graduation diploma required
- Associate's Degree or higher is preferred
- Qualified experience may be substituted for education
- 3+ years' regulatory affairs work experience in a clinical research, pharmaceutical, or site management organization highly desired
- Knowledge of medical terminology, FDA, and other regulatory processes highly preferred
- US-based work location required
- Work sponsorship is not available
Benefits:
- Comprehensive Total Rewards package supporting physical, mental, and financial well-being
- Competitive compensation package
- Annual bonus or long-term incentive opportunities may be offered
- Relocation assistance is not available
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