FSP CRA (Level II)

Clinical Research Associate (CRA)

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 opportunities to engage in meaningful work that impacts global health through the development of life-changing therapies. We support our teams with the resources needed for professional growth while advancing scientific research. Our clinical trials are conducted in over 100 countries, encompassing laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will contribute to improved 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, ensuring trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and Standard Operating Procedures (SOPs) to safeguard subject rights, well-being, and data reliability. The role also focuses on maintaining audit readiness and fostering 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 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 and Compliance:
  • 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.
  • 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 to ensure compliance with protocol and regulatory/ICH GCP obligations, making recommendations where warranted.
  • Performs trial close-out activities and retrieval of trial materials.
• Project Support and Communication:
  • Participates in the investigator payment process.
  • Shares responsibility with other project team members for issue/finding resolution.
  • Investigates and follows up on findings as applicable.
  • Participates in investigator meetings as vital.
  • 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 inquiries.

Application Instructions

• Not Specified

Company Information

Thermo Fisher Scientific At Thermo Fisher Scientific, we discover meaningful work that makes a positive impact on a global scale. We enable our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. Our PPD clinical research portfolio spans laboratory, digital, and decentralized clinical trial services, with clinical trials conducted in over 100 countries.