CRA I/II FSP EMEA📣 Job Ad

About Thermo Fisher Scientific and the Role

Thermo Fisher Scientific is seeking a Clinical Research Associate (CRA) Level I/II FSP EMEA to join its global team. The company has supported top 50 pharmaceutical companies and over 750 biotechs, managing 2,700 clinical trials across more than 100 countries in the last five years. This full-time role requires 2-5 years of experience in clinical research.

Role Overview

As a Clinical Research Associate, you will perform and coordinate all aspects of the clinical monitoring and site management process. This includes conducting remote or on-site visits to assess protocol and regulatory compliance and managing required documentation. You will manage procedures and guidelines from various sponsors and monitoring environments, acting as a site processes specialist to ensure trials adhere to approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs, thereby safeguarding subjects' rights, well-being, and data reliability. The role also involves ensuring audit readiness and fostering collaborative relationships with investigational sites.

Key Responsibilities

• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions.
• Ensure data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review via on-site and remote monitoring activities.
• Assess investigational products through physical inventory and records review.
• Document observations in reports and letters promptly, adhering to approved business writing standards.
• Escalate observed deficiencies and issues to clinical management expeditiously and ensure resolution.
• Maintain regular contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process.
• Collaborate with project team members on issue/finding resolution.
• Investigate and follow up on findings as applicable.
• Participate in investigator meetings as necessary.
• Identify potential investigators in collaboration with the client company to ensure qualified investigative sites.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with protocol, regulatory, and ICH GCP obligations.
• Perform trial close-out and retrieval of trial materials.
• Ensure essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Conduct on-site file reviews as per project specifications.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensure study systems, such as the Clinical Trial Management System, are updated per agreed study conventions.
• Facilitate effective communication between investigative sites, the client company, and the PPD project team.
• Respond to company, client, and applicable regulatory requirements, audits, and inspections.
• Complete administrative tasks, including expense reports and timesheets, in a timely manner.
• Contribute to the project team by assisting in the preparation of project publications/tools and sharing ideas/suggestions.
• Contribute to other project work and initiatives for process improvement as required.

Required Experience

Candidates for this role should possess 2-5 years of experience in clinical research or a related field, demonstrating proficiency in clinical monitoring and site management processes.

Working Conditions

• The standard work schedule is Monday to Friday.
• Work is performed in an office, laboratory, clinical, and/or home office environment, with exposure to electrical office equipment.
• Frequent drives to site locations are required.
• Frequent travel, generally 60-80%, is expected, potentially including extended overnight stays.
• Potential exposure to biological fluids and infectious organisms, requiring the use of personal protective equipment such as eyewear, garments, and gloves.
• Rare exposure to fluctuating and/or extreme temperatures.

Application Information

Salary for this position will be disclosed during the interview process. Qualified candidates are encouraged to apply.