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Foundation

A web3 destination.

Clinical Trials QA Specialist

QA EngineerQA EngineerFull TimeRemoteMid LevelTeam 11-50H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

$37 - $57 / hour

Seniority

Mid Level

Bachelor Degree2 yrs expEnglishGoogle Cloud Platform

Job Description

• Generate QA reports and quality metrics from clinical trial systems (e.g., OnCore, Medidata RAVE, CTSU, SpecTrak) to identify trends, discrepancies, and operational insights. • Prepare clear reports for research leadership to evaluate staff adherence to SOPs, workflows, and regulatory requirements. • Review clinical trial data to assess compliance with FDA regulations, ICH-GCP guidelines, sponsor requirements, and institutional policies. • Identify and escalate quality issues, data gaps, compliance risks, and process inefficiencies while recommending corrective action plans. • Collaborate with study teams and leadership to improve quality operations, support audit readiness, and enhance clinical trial oversight.

Job Requirements

  • Minimum Education: Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or other related fields.
  • Minimum Experience: 2 years of related experience
  • Familiar with Investigational New Drug procedures, study protocols, the informed consent process, Good Clinical Practices (GCPs), and applicable regulatory requirements.
  • Be able to work with large datasets, perform data analysis, assess trends, discrepancies and present findings.
  • Preferred Education: Master’s degree preferred.
  • Preferred Experience: At least one year of experience in Clinical Research for Oncology and/or Hematology clinical trials.

Benefits

  • Comprehensive Benefits

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