Quality Assurance Associate (Clinical Trial) – Evening Shift

About the role

Minerva Research Solutions is seeking a Quality Assurance Associate to support clinical trial data quality during the evening shift. The role focuses on ensuring compliance with regulatory standards and maintaining the integrity of trial data across all phases.

Key responsibilities

• Perform data‑driven Quality Monitoring activities to ensure regulatory and SOP compliance.
• Conduct quality control checks, identify source documentation errors and track non‑conformances.
• Prepare periodic clinical trial quality reports and work with clinical teams to develop risk mitigation plans.
• Share audit and inspection observations, implement corrective action plans (CAPAs), and assist in sponsor and FDA audit preparation.
• Review key trial documents for regulatory submission readiness.
• Conduct internal audits of critical processes and support cross‑functional workgroups.
• Facilitate timely resolution of compliance and quality issues through effective partnerships.
• Handle query resolution, data entry, and questionnaire preparation for assigned studies.
• Participate in additional QA projects as assigned.

Required profile

• Fresh MBBS degree with a strong interest in clinical research.
• In‑depth knowledge of FDA, GCP, ICH, and IRB guidelines for clinical trials.
• Ability to work the evening shift and maintain inspection readiness.
• Strong analytical and documentation skills.

Required skills

• FDA regulations
• GCP guidelines
• ICH guidelines
• IRB requirements
• Clinical trial data quality monitoring
• Quality control and audit preparation