Clinical Research Associate (CRA) - Various Levels

Position Overview

At Thermo Fisher Scientific, we are seeking motivated Clinical Research Associates (CRAs) at various experience levels to join our team. You will play a crucial role in performing and coordinating various aspects of the clinical monitoring and site management process, ensuring audit readiness and adherence to protocols and regulations. Our mission is to enable our customers to make the world healthier, cleaner, and safer, and your work will directly contribute to improving health outcomes globally.

Employment Type

• Full-time

Work Schedule

• Standard (Monday-Friday)

Environmental Conditions

• Office-based

Key Responsibilities

• Site Monitoring: Conduct remote or on-site visits to assess protocol and regulatory compliance. Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify and rectify site process failures.
• Data Accuracy: Ensure data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review, utilizing both on-site and remote monitoring activities.
• Investigational Product Assessment: Assess investigational product through physical inventory and records review.
• Documentation & Reporting: Document observations in reports and letters in a timely manner, adhering to approved business writing standards.
• Issue Resolution: Expedite the communication of observed deficiencies and issues to clinical management and follow all issues through to resolution. Maintain regular contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
• Compliance: Ensure trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and Standard Operating Procedures (SOPs) to guarantee subject rights, well-being, and data reliability.
• Monitoring Plan Execution: Conduct monitoring tasks in accordance with the approved monitoring plan.
• Payment Process: Participate in the investigator payment process.
• Team Collaboration: Share responsibility with other project team members for issue/finding resolution. Investigate and follow-up on findings as applicable.
• Investigator Meetings: Participate in investigator meetings as necessary.
• Site Identification & Initiation: Assist in identifying potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiate clinical trial sites according to relevant procedures, ensuring compliance with protocol and regulatory/ICH GCP obligations, and making recommendations where warranted.
• Trial Close-out: Perform trial close-out activities and retrieve trial materials.
• Essential Documents: Ensure required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conduct on-site file reviews as per project specifications.
• Reporting: Provide trial status tracking and progress update reports to the team as required.
• Study Systems: Ensure study systems are complete, accurate, and updated per agreed study conventions (e.g., Clinical Trial Management System).
• Communication: Facilitate effective communication between investigative sites, the client company, and internal project teams through written, oral, and/or electronic contacts.
• Regulatory Response: Respond to company, client, and applicable regulatory requirements/audits/inspections.
• Administrative Tasks: Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.

Company Information

At Thermo Fisher Scientific, we are dedicated to our Mission: enabling our customers to make the world healthier, cleaner, and safer. We support our teams with the resources needed to achieve individual career goals while advancing science through research, development, and the delivery of life-changing therapies. Our PPD clinical research portfolio includes clinical trials conducted in over 100 countries and the ongoing development of novel frameworks for clinical research, spanning laboratory, digital, and decentralized clinical trial services.