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Job Description:
As a Monitoring Specialist, you will be responsible for overseeing investigator sites using a risk-based monitoring approach. You will utilize root cause analysis, critical thinking, and problem-solving skills to identify and address site process failures. Your main goal is to ensure compliance, reduce risks, and maintain data accuracy through various monitoring activities.
- Monitor investigator sites using RCA and problem-solving skills to identify and address process failures.
- Ensure data accuracy through SDR, SDV, and CRF review.
- Conduct physical inventory and records review of investigational products.
- Document observations promptly following approved business writing standards.
- Communicate deficiencies and issues to clinical management efficiently.
- Maintain regular contact with investigative sites to verify protocol adherence and data recording.
- Participate in investigator meetings and assist in identifying potential investigators.
- Initiate clinical trial sites according to relevant procedures and regulations.
- Ensure trial close out and retrieval of trial materials.
- Review essential documents for completeness and compliance.
- Contribute to project publications and tools and share ideas with team members.
- Facilitate communication between sites, client company, and project team.
- Respond to regulatory requirements, audits, and inspections.
- Complete administrative tasks like expense reports and timesheets promptly.
- Participate in process improvement initiatives as needed.
