FSP CRA (Level II)

Position Overview

• Location Type: Onsite
• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)

Summary: Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites.

Requirements

• [Specific requirements are not listed in the provided text. Further details would be needed to complete this section.]

Responsibilities

• Clinical Monitoring: Monitors investigator sites with a risk-based monitoring approach.
• Risk Assessment: Applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failures and corrective/preventive actions.
• Data Accuracy: Ensures data accuracy through SDR, SDV and CRF review.
• Investigational Product Assessment: Assesses investigational product through physical inventory and records review.
• Documentation: Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalation: Escalates observed deficiencies and issues to clinical management expeditiously.
• Communication: Maintains regular contact between monitoring visits with investigative sites.
• Supervising Tasks: Conducts supervising tasks in accordance with the approved monitoring plan.
• Payment Process: Participates in the investigator payment process.
• Collaboration: Ensures a shared responsibility with other project team members on issues/findings resolution.
• Investigation & Follow-up: Investigates and follows-up on findings as applicable.
• Meetings: Participates in investigator meetings.

Salary

• [Salary information is not provided in the text.]

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 and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio.