Quality Assurance Associate (Clinical Trial)Evening Shift

Minerva Research Solutions is a clinical trial management service provider dedicated to advancing healthcare and research through high-quality clinical services. Supporting the biotech, medical, and pharmaceutical industries, we assist throughout all phases of the clinical trial lifecycle. Our expertise spans Data Operations, Recruitment Services, and Regulatory support, aiming to accelerate the development of novel therapies via streamlined processes, strict timelines, and real-time solutions. We are committed to delivering accurate data and compliant solutions, adhering to FDA and GCP regulations to ensure the success of clinical trials.

Key Responsibilities:
- Conduct comprehensive data-driven quality monitoring activities to ensure compliance with regulatory requirements and standard operating procedures, maintaining inspection readiness.
- Verify that data is recorded in alignment with sponsor protocols, GCP guidelines, industry standards, and agency regulations.
- Perform quality control checks, identifying and tracking errors or non-conformances in source documentation.
- Prepare periodic clinical trial quality reports, collaborate with clinical teams to assess risks, and develop mitigation plans.
- Share audit and inspection observations with clinical teams to promote lessons learned and support the implementation of Corrective Action Plans (CAPAs).
- Review key clinical trial documents for quality and regulatory submission readiness.
- Assist in preparation for Sponsor and FDA audits, as well as conduct internal audits to evaluate critical processes.
- Support assigned cross-functional workgroups and establish effective partnerships with internal staff to resolve compliance and quality issues promptly.
- Manage query resolution, data entry, and questionnaire preparation related to assigned studies.
- Participate in other Quality Assurance projects as assigned.
- Report directly to the Quality Assurance Lead.

Required Qualifications:
- Fresh MBBS graduates with a strong interest in clinical research are encouraged to apply.
- Solid understanding of FDA, GCP, ICH, and other relevant state and federal agency guidelines governing clinical trials.
- Familiarity with Institutional Review Board (IRB) requirements.
- Experience in external clinical/regulatory audits and document auditing is advantageous.

Preferred Skills and Abilities:
- Excellent communication skills, including interpersonal, written, and verbal abilities.
- Strong attention to detail combined with effective time management.
- Adaptability and flexibility in handling diverse work assignments.
- Capability to manage multiple tasks efficiently in a fast-paced environment.
- Professional interaction skills across all organizational levels.
- Knowledge of HIPAA Privacy Act and its application within clinical research.

Benefits:
- Competitive salary with performance-based bonuses.
- Comprehensive medical health insurance coverage.
- Employee old-age benefits.
- Support for professional learning and development.
- Generous vacation and paid time off policies.
- Employee assistance programs focusing on mental health.
- Company-sponsored events and team-building activities.
- A diverse, professional, and inclusive workplace culture.
- Opportunities for career advancement.
- Access to cutting-edge technology and tools.
- Family-friendly policies, including parental leave.
- Transportation assistance and commuter benefits.
- Engagement in social responsibility and community involvement initiatives.

This is a full-time, on-site position with three openings available for the night shift. The work schedule is Monday to Friday, from 7 PM to 3 AM. Transportation is provided for female staff, while male employees receive an allowance. Additional night shift allowances are also offered.