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Clinical Trials Quality Assurance Associate
2 weeks ago
JOB DESCRIPTION:
Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle.
Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines & real-time solutions. Our clinical trial support services & consultations are tailored to foster your product and requirements.
We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process.
Minerva Research Solution is looking for dynamic individuals with a passion for ensuring the highest standards in clinical trial data quality assurance. As a key player in our team, you will play a crucial role in maintaining the integrity and accuracy of clinical trial data.
Role SummaryAs a QA Associate, you will play a vital role in maintaining the accuracy, compliance, and quality of clinical trial data. This includes quality control, eSource/template building, EDC data entry, and supporting the team in preparing for regulatory inspections.
Key Responsibilities- Perform ongoing quality checks to ensure data accuracy and compliance with SOPs, protocols, GCP, and regulatory requirements.
- Build eSource templates tailored to study protocols and ensure standardization.
- Enter and verify data in Electronic Data Capture (EDC) systems.
- Identify and document errors or deviations; support resolution and continuous quality improvement.
- Help generate quality reports and support risk assessments in collaboration with the clinical team.
- Contribute to CAPA development and share quality learnings across protocols/programs.
- Review key study documents for consistency and regulatory readiness.
- Assist in inspection preparation and support internal quality reviews.
- Resolve queries and prepare study-specific documentation and questionnaires.
- Participate in QA projects and support cross-functional teams as needed.
- Medical or clinical background (Pharm-D, MBBS, BDS strongly preferred).
- Familiarity with FDA, GCP, ICH guidelines and IRB processes.
- 1+ year experience in QA/QC or clinical research preferred.
- Proficient in documentation, data systems, and basic regulatory concepts.
- Detail-oriented with strong communication and time management skills.
- Able to work effectively in a fast-paced, collaborative environment.
- Knowledge of HIPAA and data privacy in clinical settings.
Benefits:
- Competitive salary and performance-based bonuses.
- Medical health insurance coverage.
- Employees Old-age benefits coverage.
- Professional learning and development support.
- Generous vacation and paid time off.
- Employee assistance programs for mental health.
- Company-sponsored events and team-building activities.
- Diverse, professional, and inclusive work environment.
- Opportunities for career growth.
- Cutting-edge technology and tools.
- Family-friendly policies, including parental leave.
- Commuter benefits or transportation assistance.
- Social responsibility and community involvement programs.
Openings:
04 positions
Full-time
On-site job
Work Schedule Timings:
Monday to Friday
Evening Shift (06 PM to 02 AM)
(transport facility provided for female staff only and allowance for male employees, additional night shift allowance)
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