Clinical Research Safety Specialist

Research AnalystResearch AnalystFull TimeRemoteJuniorTeam 10,001+Since 1833H1B SponsorCompany SiteLinkedIn

Location

Tennessee

Posted

1 day ago

Salary

0

Seniority

Junior

Bachelor Degree1 yr expEnglishGoogle Cloud Platform

Job Description

Clinical Research Safety Specialist

McKesson

• Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and other applicable oversight bodies. • Maintain and organize IND Safety Reports, Investigator Brochures, and other essential regulatory documentation. • Monitor and support compliance with federal regulations, sponsor requirements, and institutional policies. • Assist with regulatory submissions and ongoing regulatory affairs activities for industry-sponsored and investigator-initiated clinical trials. • Partner with Regulatory Affairs leadership, study teams, and Principal Investigators to ensure regulatory requirements are met. • Support audit and inspection readiness by maintaining complete, accurate, and current regulatory files. • Track deadlines and manage multiple priorities while ensuring timely completion of submissions and compliance-related activities. • Other duties as assigned.

Job Requirements

  • Bachelor's Degree required
  • Minimum 1+ years' professional work experience in a clinical research, biotechnology, life sciences, pharmaceutical or hospital environment
  • Work experience should include knowledge of IRB, FDA, and GCP guidelines required
  • Work experience of scientific and clinical research terminology required
  • Above average skills with all MS Office products including Excel, Word, Outlook
  • Exceptional organizational skills required.

Benefits

  • Comprehensive benefits to support physical, mental, and financial well-being.

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