Research Regulatory Affairs Specialist

Job Description:

• 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
• Establish and maintain document management systems for regulatory electronic files
• Maintain FDA- and GCP-required regulatory documentation for sites, studies, sponsors, and/or networks
• Ensure regulatory documentation complies with local Standard Operating Procedures for format and content
• Maintain critical documentation for compliance
• Modify and/or develop informed consent forms
• Update and manage protocol, investigator drug brochure, and consent form modifications or amendments in compliance with IRB policy and HIPAA
• Handle 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 preferred
• Qualified experience may be substituted for education
• 1+ year work experience in clinical research, pharmaceutical, or site management organization work focused on regulatory affairs highly desired
• Knowledge of medical terminology highly preferred
• Knowledge of FDA and other regulatory processes highly preferred
• Ability to manage a full study workload with minimal supervision
• Knowledge of IRB policy and HIPAA compliance
• Familiarity with FDA and GCP regulatory documentation requirements
• Ability to meet strict deadlines and prepare for auditing activities

Benefits:

• Total Rewards package including comprehensive benefits supporting physical, mental, and financial well-being
• Competitive compensation package
• Annual bonus or long-term incentive opportunities may be offered
• Equity may be included in compensation
• McKesson benefits offerings