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 offerings include Data Operations, Recruitment Services, and Regulatory support, all designed to accelerate the development of novel therapies by implementing streamlined processes, strict timelines, and real-time solutions. We are committed to delivering accurate data and effective solutions while adhering to stringent FDA and GCP regulations.

We are currently seeking motivated individuals passionate about maintaining the highest standards in clinical trial data quality assurance. As a vital member of our team, you will ensure the integrity and accuracy of clinical trial data, contributing significantly to the success of our projects.

Key Responsibilities:
- Conduct comprehensive data-driven quality monitoring activities to ensure compliance with regulatory requirements and standard operating procedures, maintaining inspection readiness at all times.
- Verify that data is recorded in accordance with sponsor protocols, GCP guidelines, industry standards, and agency regulations.
- Perform quality control checks, identify, and track errors or non-conformances in source documentation.
- Provide ongoing compliance support, including preparing periodic clinical trial quality reports for assigned programs and collaborating with clinical teams to identify risks and develop mitigation plans.
- Work closely with clinical teams to share audit and inspection observations, facilitating lessons learned and implementing 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 within the organization to resolve compliance and quality issues promptly.
- Manage query resolution, data entry, and questionnaire preparation related to respective 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 highly encouraged to apply.
- Solid understanding of FDA, GCP, ICH, and other relevant state and federal guidelines governing clinical trials.
- Knowledge of Institutional Review Board (IRB) requirements.
- Experience with external clinical/regulatory audits and document auditing is advantageous.

Preferred Qualifications and Benefits:
- Excellent communication skills, both written and verbal, with strong interpersonal abilities.
- High attention to detail coupled with effective time management skills.
- Flexibility in handling various work assignments and the ability to manage multiple tasks in a fast-paced environment.
- Professional demeanor with the ability to interact at all organizational levels.
- Familiarity with HIPAA Privacy Act and its application in clinical research.

We offer a competitive salary with performance-based bonuses, comprehensive medical insurance, and old-age benefits coverage. Employees receive professional development support, generous vacation and paid time off, and access to mental health assistance programs. Our company fosters a diverse, inclusive, and family-friendly workplace, including parental leave and commuter benefits. Team-building activities, company-sponsored events, and opportunities for career advancement are integral to our culture. We also emphasize social responsibility and community involvement.

Openings:
- 3 full-time positions available (Night shift)
- On-site work required

Work Schedule:
- Monday to Friday, 7 PM to 3 AM
- Transport facility provided for female staff; allowance offered for male employees
- Additional night shift allowance included

This role offers a unique opportunity to contribute to impactful clinical research while working in a supportive and dynamic environment.