Night-Shift QA Specialist - Clinical Trials Data Integrity

Minerva Research Solutions; Karachi Division; On-site; PKR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Medical health insurance

Employee assistance programs

Paid time off

Parental leave

Transportation assistance

Career growth opportunities

Job summary

Minerva Research Solutions is seeking QA Associate professionals to support clinical trial data Quality Assurance. The role focuses on data accuracy, regulatory compliance, and audit readiness within a fast-paced environment.

The successful candidates will hold an MBBS with interest in clinical research, knowledge of GCP/FDA guidelines, and the ability to manage multiple tasks during night shifts at the on-site facility in Karachi. 3 openings, full-time.

Qualifications

• Fresh MBBS with keen interest in Clinical Research.
• In-depth knowledge of FDA, GCP, ICH and other guidelines for clinical trials.
• Knowledge of IRB requirements.
• Experience including external clinical/regulatory auditing will be a plus.

Responsibilities

• Perform comprehensive data-driven Quality Monitoring activities to ensure regulatory compliance and inspection readiness.
• Ensure data is recorded per sponsor protocol, GCP guidelines and agency regulations.
• Perform quality control checks; identify and track source documentation errors and non-conformances.
• Provide ongoing compliance support and prepare periodic clinical trial quality reports with the team to identify risks and mitigation plans.
• Collaborate with Clinical Team to share audit observations and implement CAPAs.
• Review key documents for use in trials and for regulatory submissions.
• Assist in preparing for Sponsor and FDA audits and conduct internal audits.
• Support cross-functional workgroups and foster quality process improvements.

Skills

Communication

Attention to detail

Time management

Multitasking

Professional interaction

HIPAA knowledge

Education

MBBS (Fresh)

Job description

Minerva Research Solutions is seeking QA Associate professionals to support clinical trial data Quality Assurance. The role focuses on data accuracy, regulatory compliance, and audit readiness within a fast-paced environment.

The successful candidates will hold an MBBS with interest in clinical research, knowledge of GCP/FDA guidelines, and the ability to manage multiple tasks during night shifts at the on-site facility in Karachi. 3 openings, full-time.