Clinical Trial Data Assurance Specialist

1 day ago


Karachi, Sindh, Pakistan Minerva Research Solutions Full time
Clinical Trial Data Assurance Specialist

We are seeking a highly skilled Clinical Trial Data Assurance Specialist to join our team at Minerva Research Solutions. As a key player in our organization, you will play a vital role in maintaining the integrity and accuracy of clinical trial data.

Key Responsibilities:

  • Perform comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs.
  • Ensure data is recorded in accordance with sponsor protocol, GCP guidelines, industry guidelines and agency regulations.
  • Identify and track source documentation errors and non-conformances with requirements.
  • Collaborate with the Clinical Team to develop risk mitigation plans.
  • Review and implement Corrective Action Plans (CAPAs) based on audit/inspection observations.
  • Assist in preparing for all Sponsor and FDA audits.

Requirements:

  • Medical Graduate with a keen interest in Clinical Research.
  • In-depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials.
  • Knowledge of IRB requirements.


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