Quality Assurance Associate – Clinical Trials (Evening Shift)
Minerva Research Solutions · Karachi
Job description
About the role
Minerva Research Solutions is a clinical‑trial management service provider that supports biotech, medical and pharma industries across the trial lifecycle. The Quality Assurance Associate will play a crucial role in maintaining the integrity and accuracy of clinical‑trial data during the evening shift.
Key responsibilities
- Perform data‑driven quality monitoring to ensure compliance with FDA, GCP, SOPs and inspection readiness.
- Conduct quality control checks, identify source‑document errors and track non‑conformances.
- Prepare periodic quality reports, assess risks with clinical teams and develop mitigation plans.
- Collaborate on audit/inspection observations, implement corrective action plans (CAPAs) and support internal and sponsor audits.
- Review key trial documents for regulatory submission and assist cross‑functional workgroups.
Required profile
- Fresh MBBS graduate with strong interest in clinical research.
- In‑depth knowledge of FDA, GCP, ICH guidelines and IRB requirements.
- Familiarity with HIPAA privacy regulations applicable to clinical research.
- Experience with external clinical/regulatory document auditing is a plus.
What we offer
- Competitive salary with performance‑based bonuses.
- Medical health insurance and old‑age benefits.
- Flexible work hours, remote‑work options and night‑shift allowance.
- Professional learning and development support.
- Generous vacation and paid time off.
- Employee assistance programs for mental health.
- Company‑sponsored events, team‑building activities and an inclusive work environment.
- Opportunities for career growth and access to cutting‑edge technology.
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Published 1 week ago
Expires 1 month from now
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Minerva Research Solutions
Karachi