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2+ years years
Not Disclosed
10 Aug. 29, 2025
Job Description
Job Type: Remote Education: Bachelor’s degree in a life science or nursing field OR Registered Nursing certification with relevant qualifications Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Clinical Research Associate (CRA) – Level II


Location:

  • Remote, India

  • Work Type: Full-time

  • Job ID: R-01326248

  • Work Environment: Fully Onsite

  • Work Schedule: Standard (Monday–Friday)

  • Environmental Conditions: Office


About the Company

Thermo Fisher Scientific, through its PPD® clinical research services, leads global efforts in clinical research by supporting the development and delivery of life-changing therapies. With operations in over 100 countries, the company is dedicated to making the world healthier, cleaner, and safer.


Department: Clinical Operations

Clinical Operations at PPD provides end-to-end support for clinical trials—from start-up to close-out—on commercial and government contracts. The team focuses on minimizing delays, ensuring compliance, and conducting high-quality, cost-effective studies.


Position Summary

The CRA (Level II) is responsible for monitoring and managing investigational sites in clinical trials. This includes conducting remote or on-site visits to assess protocol compliance, data integrity, and regulatory adherence. The CRA ensures that trials follow GCP guidelines and maintains a strong working relationship with site personnel.


Key Responsibilities

Monitoring & Site Management

  • Perform risk-based monitoring using critical thinking and RCA.

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

  • Assess investigational product inventory and documentation.

  • Conduct monitoring visits (initiation, interim, and close-out).

  • Maintain regular contact with site staff between visits.

Regulatory Compliance

  • Ensure adherence to ICH-GCP, SOPs, protocol, and applicable regulations.

  • Ensure essential documents are complete and audit-ready.

  • Escalate and follow through on protocol deviations and deficiencies.

Project & Documentation Support

  • Participate in investigator meetings and site selection.

  • Manage investigator payments and update CTMS (Clinical Trial Management System).

  • Track study progress and report to Clinical Team Manager (CTM).

  • Maintain project systems and documentation in compliance with conventions.

  • Support audit and inspection responses as needed.

Team Collaboration

  • Collaborate with project teams on issue resolution.

  • Share process improvement ideas.

  • Assist in developing trial publications/tools.

  • Maintain accurate timesheets and expense reports.


Qualifications

Education:

  • Bachelor’s degree in a life science or nursing field
    OR

  • Registered Nursing certification with relevant qualifications

Experience:

  • Minimum 2+ years of on-site clinical research monitoring

  • Valid driver’s license (as applicable)

  • Equivalent combinations of education and experience will be considered


Key Skills & Competencies

  • Strong clinical monitoring skills

  • Working knowledge of ICH-GCP and regulatory procedures

  • Medical/therapeutic area understanding and medical terminology

  • Excellent critical thinking and problem-solving abilities

  • Familiarity with Risk-Based Monitoring (RBM) processes

  • Effective oral and written communication

  • Excellent attention to detail and organizational skills

  • Ability to work independently or as part of a team

  • Solid Microsoft Office skills and comfort with clinical systems

  • Proficient in English, with strong grammar and presentation skills


Work Environment Requirements

  • Ability to:

    • Communicate and understand diverse perspectives

    • Work in upright, stationary positions for extended periods

    • Use office equipment and software tools proficiently

    • Manage multiple projects under pressure

    • Travel independently (up to XX%, via car, plane, or train)

    • Occasionally be exposed to healthcare or lab environments


Why Join Thermo Fisher Scientific?

  • Contribute to meaningful work that has a global impact

  • Thrive in a supportive, diverse, and inclusive environment

  • Access to award-winning learning and development programs

  • Opportunity to grow your career while improving patient lives


Equal Opportunity Statement

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or protected veteran status.


Apply Now at thermofisher.com/careers