FSP CRA (Level I/II)

Position Overview

• Location Type: Onsite
• Employment Type: Full Time
• Salary: Not Provided
• Summary: Thermo Fisher Scientific is seeking a dedicated and detail-oriented Clinical Trial Monitor to ensure the integrity and compliance of clinical trials. This role involves monitoring investigator sites using a risk-based approach, identifying process failures, and implementing corrective and preventive actions. The successful candidate will contribute to data accuracy, product assessment, and overall trial success.

Requirements

• Education and Experience:
  • Strong background in Health Surveillance Administration (HSA) and Institutional Review Board (IRB) submissions.
  • Substantial knowledge in ECOS (Electronic Clinical Outcomes System).
  • Demonstrated ability to ensure the completeness and accuracy of essential documents according to ICH-GCP and applicable regulations.
  • Experience conducting on-site file reviews as per project specifications.

Responsibilities

• Monitoring Site Activities:
  • Monitors investigator sites with a risk-based monitoring approach.
  • Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures.
  • Implements corrective and preventive actions to bring sites into compliance and decrease risks.
• Data Quality Assurance:
  • Reviews Source Data Records (SDR), Source Data Verification (SDV), and Case Report Forms (CRF) as applicable.
  • Ensures data accuracy through on-site and remote monitoring activities.
• Product Assessment:
  • Conducts physical inventory and records review of investigational products.
• Reporting and Communication:
  • Documents observations in reports and letters using approved business writing standards.
  • Brings up observed deficiencies and issues to clinical management expeditiously.
  • Follows issues through to resolution.
  • Maintains regular contact with investigative sites to ensure protocol adherence and issue resolution.
• Collaboration and Support:
  • Participates in investigator meetings.
  • Assists in identifying potential investigators in collaboration with the client company.
  • Initiates clinical trial sites according to procedures.
  • Performs trial close-out and retrieval of trial materials.
  • Shares responsibility with other project team members for issue resolution.
  • Investigates and follows up on findings as applicable.

Application Instructions

• Not Provided

Company Information

• Company: Thermo Fisher Scientific
• Mission: Enabling our customers to make the world healthier, cleaner and safer.
• Services: Clinical trials conducted in 100+ countries, PPD clinical research portfolio (clinical research services).