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.

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data analysisquality metrics generationclinical trial data reviewcompliance assessmentreport preparationtrend identificationdiscrepancy assessmentcorrective action planninglarge dataset managementaudit readiness support

Soft Skills

collaborationcommunicationproblem-solvingattention to detailorganizational skills

Certifications

Bachelor’s degreeMaster’s degree (preferred)