Clinical Research Associate CRA I FSP Jobs – Thermo Fisher Scientific

Thermo Fisher Scientific CRA I – FSP Jobs | Clinical Research

Thermo Fisher Scientific is recruiting for a Clinical Research Associate I (CRA I – FSP) position within its PPD® clinical research business. This opportunity is suited to candidates with a Master’s degree in Life Sciences, preferably Pharmacy, and 1–2 years of independent on-site clinical monitoring experience. The role involves clinical trial site monitoring, protocol compliance, Source Data Verification (SDV), Source Data Review (SDR), investigator site management, and regulatory documentation. Candidates with experience conducting clinical trial site visits across India are required, while oncology trial monitoring experience is preferred.

Company Overview

Thermo Fisher Scientific provides clinical research services through its PPD® clinical research portfolio. Its clinical research teams support drug development by helping ensure that clinical trials follow approved protocols, applicable regulations, and International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines.

Job Details

• Company: Thermo Fisher Scientific

• Clinical Research Business: PPD®

• Designation: Clinical Research Associate I (CRA I – FSP)

• Job Requisition ID: R-01368661

• Work Schedule: Standard, Monday to Friday

• Work Environment: Office, with on-site and remote clinical monitoring activities

• Experience: 1–2 years of independent on-site clinical monitoring experience

• Travel Requirement: May exceed 75%

Job Role & Responsibilities

Clinical Trial Site Monitoring

• Monitor investigator sites using a risk-based monitoring approach.

• Conduct on-site and remote monitoring visits to assess compliance with clinical trial protocols, regulatory requirements, ICH-GCP, and applicable SOPs.

• Perform Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) reviews, as applicable.

• Assess investigational products through physical inventory checks and records review.

• Conduct monitoring activities according to the approved monitoring plan.

• Initiate clinical trial sites in accordance with relevant procedures and compliance requirements.

• Perform clinical trial close-out activities and retrieve trial materials.

Data Quality & Risk Management

• Apply root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures.

• Determine corrective and preventive actions to address findings and bring sites into compliance.

• Identify and reduce study-level and site-level risks.

• Document observations in monitoring reports and letters within required timelines.

• Escalate deficiencies and issues to clinical management and follow them through to resolution.

• Investigate and follow up on findings, as applicable.

• Recommend appropriate actions regarding site compliance.

Regulatory Documentation & Compliance

• Ensure essential clinical trial documents are complete and maintained according to ICH-GCP and applicable regulations.

• Conduct on-site file reviews according to project specifications.

• Maintain audit readiness and respond to company, client, regulatory audit, and inspection requirements.

• Ensure study systems and the Clinical Trial Management System (CTMS) are complete, accurate, and updated.

• Maintain compliance with approved protocols, regulatory requirements, and monitoring procedures.

Investigator Site & Project Coordination

• Maintain regular contact with investigative sites between monitoring visits to confirm protocol compliance, timely data entry, and resolution of outstanding issues.

• Facilitate communication between investigative sites, client companies, and internal project teams.

• Participate in investigator meetings when required.

• Support investigator payment processes.

• Assist in identifying potential investigators and suitable clinical trial sites when required.

• Provide trial status updates and progress reports to project teams.

• Complete administrative activities, including expense reports and timesheets.

• Contribute to project publications, monitoring tools, and process-improvement initiatives.

Eligibility & Qualifications

Candidates should meet the following requirements:

• Educational Qualification: Master’s degree in a Life Sciences-related field, preferably Pharmacy.

• Experience: 1–2 years of independent on-site clinical monitoring experience is mandatory.

• Site Visit Experience: Hands-on experience conducting clinical trial site visits across India.

• Preferred Experience: Monitoring oncology clinical trials.

• Clinical Research Knowledge: Understanding of clinical trial processes, medical terminology, and therapeutic areas.

• Regulatory Knowledge: Working knowledge of ICH-GCP requirements, applicable regulations, and relevant procedural documents.

• Risk-Based Monitoring: Ability to manage risk-based monitoring concepts and processes.

• Analytical Skills: Critical thinking, root cause analysis, investigation, and problem-solving abilities.

• Communication: Good written and verbal English skills and the ability to communicate effectively with medical personnel.

• Organizational Skills: Strong time management, attention to detail, interpersonal skills, and adaptability.

• Computer Skills: Proficiency in Microsoft Office and the ability to learn and use relevant clinical research software systems.

Work Schedule & Travel Requirements

The role follows a Monday-to-Friday standard work schedule. Although the listing identifies an office work environment, the responsibilities include both on-site and remote monitoring activities.

Travel may exceed 75%, so candidates should be prepared to travel extensively for clinical trial site visits across India.

 

How to Apply

Interested and eligible candidates can apply through the official Thermo Fisher Scientific careers portal.

Apply Online: Thermo Fisher Scientific CRA I – FSP Recruitment

Before applying, ensure that your resume clearly highlights independent site monitoring experience, clinical trial site visits, ICH-GCP knowledge, and experience with SDV, SDR, and risk-based monitoring.

Job Summary