FSP CRA (Level II)

Position Overview

• Location Type: Onsite (Potential for Remote Components)
• Employment Type: Full-time
• Salary: Not specified in the provided text.

This role involves performing and coordinating various aspects of clinical monitoring and site management. The position requires conducting remote or on-site visits to assess protocol and regulatory compliance, manage required documentation, and act as a site processes specialist, ensuring trial adherence to guidelines and regulations.

Requirements

• Not specified in the provided text. (Likely includes experience in clinical research, knowledge of GCP guidelines, and strong communication skills)

Responsibilities

• Clinical Monitoring & Site Management: Conducts remote or on-site visits to assess protocol and regulatory compliance.
• Documentation Management: Manages required documentation for clinical trials.
• Compliance Assurance: Ensures that trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs.
• Risk-Based Monitoring: Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions.
• Data Accuracy: Monitors data accuracy through SDR, SDV, and CRF review.
• Investigational Product Assessment: Conducts physical inventory and records review of investigational products.
• Reporting & Escalation: Documents observations in reports and letters, and escalates deficiencies to clinical management.
• Site Communication: Maintains regular contact with investigative sites to confirm protocol adherence and issue resolution.
• Supervising Tasks: Performs supervising tasks in accordance with the monitoring plan.
• Investigator Payment: Participates in the investigator payment process.
• Collaboration: Works collaboratively with project team members to resolve issues and findings.
• Investigator Meetings: Participates in investigator meetings.

Company Information

• Company: Thermo Fisher Scientific
• Mission: Enabling our customers to make the world healthier, cleaner, and safer.
• Services: Provides clinical trial services including laboratory, digital, and decentralized clinical trial services.
• Clinical Trials: Conducts clinical trials in over 100 countries and develops novel frameworks for clinical research.