QA Associate Night Shift (Clinical Trials)

Job Summary
Minerva Research Solutions is a leading clinical trial management service provider committed to advancing healthcare and research through exceptional clinical services. We support biotech, medical, and pharmaceutical sectors across all phases of the clinical trial lifecycle, specializing in Data Operations, Recruitment Services, and Regulatory support. Our goal is to accelerate the development of innovative therapies by implementing efficient processes, adhering to strict timelines, and delivering real-time solutions. We maintain full compliance with FDA and GCP regulations at every stage, offering customized support tailored to your product and project requirements.

We are currently seeking a Quality Assurance (QA) Associate to join our team. This full-time, on-site role reports directly to the Quality Assurance Lead. The position offers a Monday to Friday schedule from 6 PM to 2 AM, with transport facilities provided for female employees and allowances for male employees. There are three openings available.

Key Responsibilities
The QA Associate will conduct thorough, data-driven Quality Monitoring activities to ensure adherence to regulatory requirements and Standard Operating Procedures (SOPs), maintaining a state of inspection readiness. You will verify that clinical trial data is accurately recorded in line with sponsor protocols, Good Clinical Practice (GCP) guidelines, industry standards, and agency regulations.

Your role includes performing quality control checks, identifying and tracking errors in source documentation, and managing non-conformances. You will prepare periodic clinical trial quality reports for assigned programs, collaborate with clinical teams to assess risks, and contribute to developing risk mitigation strategies.

Close collaboration with the Clinical Team is essential to share audit and inspection findings, facilitate lessons learned across protocols or programs, and support the implementation of Corrective Action Plans (CAPAs). You will review key clinical trial documents to ensure quality and regulatory submission readiness.

Additionally, you will assist in preparing for Sponsor and FDA audits, conduct internal audits to evaluate critical processes, and provide support to cross-functional workgroups. Establishing effective partnerships within the organization to resolve compliance and quality issues promptly is a key aspect of this role.

The QA Associate will also manage query resolution, data entry, and questionnaire preparation related to assigned studies. You may be assigned additional Quality Assurance projects by leadership as needed.

Required Qualifications
We encourage fresh MBBS graduates with a strong interest in Clinical Research to apply. Candidates should have a solid understanding of FDA, GCP, ICH, and other relevant federal and state agency guidelines governing clinical trials. Knowledge of Institutional Review Board (IRB) requirements and familiarity with the HIPAA Privacy Act as it applies to clinical research is essential.

Excellent communication skills, including interpersonal, written, and verbal abilities, are required. The ideal candidate will demonstrate strong attention to detail, effective time management, and the ability to manage multiple tasks in a fast-paced environment. A professional demeanor and the ability to interact effectively at all organizational levels are also important.

Preferred Qualifications and Benefits
Experience in external clinical or regulatory auditing and document auditing is advantageous. We offer a competitive salary with performance-based bonuses, comprehensive medical health insurance, and employees’ old-age benefits coverage.

Our commitment to professional growth includes support for learning and development, generous vacation and paid time off, and employee assistance programs focused on mental health. We foster a diverse, inclusive, and professional work environment with company-sponsored events and team-building activities.

Additional benefits include opportunities for career advancement, access to cutting-edge technology and tools, family-friendly policies such as parental leave, commuter benefits or transportation assistance, and engagement in social responsibility and community involvement initiatives.

Join Minerva Research Solutions and contribute to transforming clinical research while advancing your career in a supportive and dynamic environment.