Clinical Research Associate

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Location Type: Office

Position Overview

At Thermo Fisher Scientific, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. We empower our teams with the resources needed to achieve individual career goals and advance scientific discovery through the development and delivery of life-changing therapies. With a global presence in clinical trials and a focus on innovative research frameworks, our work spans laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will directly contribute to improving health outcomes for individuals and communities.

Summarized Purpose

The Clinical Research Associate (CRA) performs and coordinates various aspects of clinical monitoring and site management. This role involves conducting remote or on-site visits to ensure protocol and regulatory compliance, managing essential documentation, and adhering to sponsor and supervisory guidelines. The CRA acts as a site processes specialist, guaranteeing adherence to the approved protocol, ICH-GCP guidelines, applicable regulations, and Standard Operating Procedures (SOPs) to protect subject rights, well-being, and data integrity. The position also ensures audit readiness and fosters collaborative relationships with investigational sites. Detailed tasks and responsibilities are 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 and implement corrective/preventive actions.
  • Ensures data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review via on-site and remote activities.
  • 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 ensures their 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 project team members on issue/finding resolution.
  • Investigates and follows up on findings as applicable.
  • Participates in investigator meetings as needed.
  • Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  • Initiates clinical trial sites according to relevant procedures, ensuring compliance with protocol and regulatory/ICH GCP obligations, and makes 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 are updated per agreed study conventions (e.g., Clinical Trial Management System).
  • 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, and inspections.

Environmental Conditions

• Office environment.