FSP CRA (Level II)

Position Overview

• Location Type: Onsite
• Employment Type: Full Time
• Salary: Not specified
• 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

• Not specified

Responsibilities

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Assesses investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
• May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
• Conducts supervising tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process.
• Ensures a shared responsibility with other project team members on issues/findings resolution.
• Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as vital.

Company Information

• Company: Thermo Fisher Scientific
• Mission: Enabling our customers to make the world healthier, cleaner and safer.
• Work Environment: Office
• Work Schedule: Standard (Mon-Fri)
• Clinical Trials: Conducted in 100+ countries, ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio.