Clinical Research Associate (CRA) - All Levels

Position Overview

• Location Type: Not Specified
• Employment Type: Full Time
• Work Schedule: Standard (Mon-Fri)
• Salary: Not Specified
• Brief Description: 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 monitoring 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 information would be needed to list specific skills, education, or experience.

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 to ensure ongoing compliance.

Company Information

• Company: Thermo Fisher Scientific
• Mission: Enabling our customers to make the world healthier, cleaner and safer.
• Services: Clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Provides laboratory, digital and decentralized clinical trial services.

Application Instructions

• Application instructions are not provided in the text. Further information would be needed to provide details on how to apply.