Clinical Research Associate

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Location Type: Office Salary: Not specified Environmental Conditions: Office

Position Overview

At Thermo Fisher Scientific, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. Our PPD clinical research portfolio offers a unique opportunity to contribute to life-changing therapies through cutting-edge research, development, and delivery. We support our teams with the resources necessary to achieve individual career goals and advance scientific frontiers. With clinical trials conducted in over 100 countries, our work encompasses laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will directly impact health outcomes for individuals and communities, both now and in the future.

Summarized Purpose

This role involves performing and coordinating various aspects of clinical monitoring and site management. The Clinical Research Associate will conduct remote or on-site visits to assess protocol and regulatory compliance, manage essential documentation, and ensure adherence to sponsor and supervisory guidelines (e.g., FSO, FSP, Government). As a site processes specialist, you will ensure trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, safeguarding subject rights, well-being, and data reliability. You will also ensure audit readiness and foster collaborative relationships with investigational sites. Detailed tasks and responsibilities will be outlined in the task matrix.

Key Responsibilities

• Site Monitoring:
  • Monitors investigator sites using a risk-based monitoring approach.
  • Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures.
  • Develops and implements corrective/preventive actions to ensure site compliance and mitigate risks.
  • Ensures data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review via on-site and remote monitoring.
  • Assesses investigational product through physical inventory and records review.
  • Documents observations in reports and letters promptly, adhering to approved business writing standards.
  • Escalates observed deficiencies and issues to clinical management expeditiously and follows through to resolution.
  • Maintains regular contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording.
  • Conducts supervising tasks in accordance with the approved monitoring plan.
• Site Management & Compliance:
  • Participates in the investigator payment process.
  • Collaborates with other project team members on issue/finding resolution.
  • Investigates and follows up on findings as applicable.
  • Participates in investigator meetings as required.
  • Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified sites.
  • Initiates clinical trial sites according to relevant procedures, ensuring compliance with protocol and regulatory/ICH GCP obligations, and making recommendations where warranted.
  • Performs trial close-out activities and retrieves trial materials.
  • Ensures required essential documents are complete and in place according to ICH-GCP and applicable regulations.
  • Conducts on-site file reviews as per project specifications.
• Reporting & Communication:
  • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
  • Ensures study systems (e.g., Clinical Trial Management System) are updated per agreed study conventions.
  • Facilitates effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic contacts.
  • Responds to company, client, and applicable regulatory requirements/audits.

Company Information

Thermo Fisher Scientific is a global leader in serving science, with a mission to enable customers to make the world healthier, cleaner, and safer. Our PPD clinical research portfolio is a key part of our commitment to advancing global health.