Quality Assurance Associate (Clinical Trial) - Evening Shift

About the role

Minerva Research Solutions is a clinical trial management service provider supporting the biotech, medical and pharma industries through data operations, recruitment services and regulatory services, following FDA and GCP regulations. It is hiring three full-time, on-site Quality Assurance Associates for the night shift (7 PM to 3 AM, Monday to Friday) to maintain the integrity and accuracy of clinical trial data. The QA Associate reports to the Quality Assurance Lead.

Key responsibilities

• Perform data-driven quality monitoring to ensure compliance with regulatory requirements and SOPs and to stay inspection-ready
• Record data according to sponsor protocol, GCP guidelines, industry guidelines and agency regulations
• Run quality control checks, identify and track source documentation errors and non-conformances
• Prepare periodic clinical trial quality reports, assess them with the clinical team, and help develop risk mitigation plans
• Share audit and inspection observations with the clinical team and help implement Corrective Action Plans (CAPAs)
• Review key clinical trial documents and assist in preparing for sponsor and FDA audits and internal audits
• Support cross-functional workgroups, resolve queries, enter data and prepare questionnaires for studies

Required profile

• Fresh MBBS graduates with an interest in clinical research are strongly encouraged to apply
• In-depth knowledge of FDA, GCP, ICH and other state and federal agency guidelines for clinical trials
• Knowledge of IRB requirements
• Experience in external clinical/regulatory and document auditing is a plus

Required skills

• Good written and verbal communication skills
• Attention to detail, time management and ability to handle multiple tasks in a fast-paced environment
• Knowledge of HIPAA Privacy Act and its application to clinical research

What we offer

• Competitive salary and performance-based bonuses
• Medical and old-age insurance coverage
• Learning and development support, generous vacation and paid time off
• Employee assistance programs, family-friendly policies including parental leave, commuter benefits and social responsibility programs