
Clinical Trial Data Assurance Specialist
1 day ago
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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