Clinical Regulatory Affairs Specialist II

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1833H1B SponsorCompany SiteLinkedIn

Location

Tennessee

Posted

6 days ago

Salary

Not specified

Seniority

Senior

Associate Degree3 yrs expExperience acceptedEnglishGoogle Cloud Platform

Job Description

• Managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. • Working closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance. • Preparing for auditing activities while meeting strict deadlines. • Maintaining a full study workload with minimal supervision. • Establishing and maintaining a document management system for regulatory electronic files • Maintaining FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. • Ensuring all regulatory documentation is compliant with local Standard Operating Procedures (SOPs) for format and content. • Maintaining critical documentation ensuring compliance. • Modifying and/or developing informed consent forms and updates and managing protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA. • Organizing and processing documentation for IRB submission for multiple trials. • Processing of Protocol Deviations that meet the IRB reportable criteria. • Submitting urgent safety notifications to the IRB.

Job Requirements

  • Associate's Degree or higher is preferred, high school graduation diploma required - qualified experience may be substituted for education
  • 3+ years' regulatory affairs work experience in a clinical research, pharmaceutical, site management organization highly desired
  • Knowledge of medical terminology, FDA, other regulatory processes highly preferred.

Benefits

  • Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being.
  • Professional development opportunities.

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