Job Vacancy at Thermo Fisher Scientific

Job Vacancy at Thermo Fisher Scientific

POSITION: 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.
• It may be necessary to maintain regular contact with investigation sites in between monitoring visits to ensure that the procedure is followed, previously highlighted concerns are remedied, and data is captured on time.
• Performs supervisory tasks under the authorized monitoring strategy.
• Participates in the investigator’s payment process. Ensures that all project team members share responsibility for resolving issues/findings.
• Investigate and follow up on findings as needed.
• Ensures that all necessary documentation is complete and in place, under ICH-GCP and related requirements. Conducts on-site file reviews under project specifications.
• Provides trial status tracking and progress update information to the Clinical Team Manager (CTM) as needed.
• Ensures that study systems are updated under 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.
• Contribute 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 Job Vacancy at Thermo Fisher Scientific

Click Here to Apply Online

Closing Date: July 25, 2024

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