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New Job Opportunity at Thermo Fisher Scientific
Job Title: CRA (Level II)
Job Description
- Performs and coordinates many parts of the clinical monitoring and site management procedures.
- Conducts remote or on-site visits to ensure protocol and regulatory compliance, and handles necessary documentation.
- Manages processes and rules from various sponsors and/or overseeing environments (e.g., FSO, FSP, government).
- Acts as a site processes specialist, ensuring that the trial is carried out in compliance with the authorized protocol, ICH-GCP guidelines, applicable regulations, and SOPs to protect the subjects’ rights, well-being, and data reliability.
- Maintains audit preparedness. Forms collaborative partnerships with investigational sites. The task matrix outlines the detailed tasks and responsibilities assigned to each function.
Key Responsibilities:
- Monitors investigator sites using a risk-based approach, applying root cause analysis (RCA), critical thinking, and problem-solving abilities to discover process failures and corrective/preventive actions to bring the site into compliance and reduce risks.
- Ensures data accuracy by conducting SDR, SDV, and CRF reviews as needed through on-site and remote monitoring activities.
- Examine the experimental product by physical inventory and records review.
- Observations are documented in reports and letters on a timely basis, following authorized corporate writing standards.
- Escalates detected defects and difficulties to clinical management as soon as possible, and ensures that all issues are resolved.
- Performs supervisory tasks in accordance with the authorized monitoring strategy.
- Participates in the investigator’s payment process. Ensures that all project team members share responsibility for resolving issues/findings.
- Investigates and follows up on findings as needed.
- Provides trial status tracking and progress update information to the Clinical Team Manager (CTM) as needed.
- Ensures that study systems are updated in accordance with agreed-upon study conventions (for example, the Clinical Trial Management System).
- Facilitates effective communication across investigative sites, the client company, and the PPD project team via written, oral, and/or electronic means.
- Responds to company and client requirements, as well as any appropriate regulatory audits or inspections.
- Maintains and completes administrative activities such as expense reports and timesheets in a timely fashion.
- Contributes to the project team by assisting with the creation of project publications/tools and discussing ideas/suggestions with teammates.
- Contributes to various projects and efforts for process improvement as needed.
How to Apply for this New Job Opportunity at Thermo Fisher Scientific
Closing Date: May 10, 2024
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