Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Cra (Level I, Level Ii And Sr Cra)

Thermo Fisher Scientific
Thermo Fisher Scientific
2-5 years
Not Disclosed
10 Jan. 20, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Clinical Research Associate (CRA I / CRA II / Senior CRA) – India

Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Location: India (Onsite Role; Remote location base as per project requirement)
Job ID: R-01326248
Job Type: Full-time
Category: Clinical Research / Clinical Operations
Work Schedule: Monday to Friday (Standard Business Hours)


Job Overview

Thermo Fisher Scientific, through its PPD® Clinical Research Services division, is hiring Clinical Research Associates (CRA Level I, Level II, and Senior CRA) to support global clinical trials across multiple therapeutic areas. This role is critical in ensuring that clinical studies are conducted in compliance with ICH-GCP, regulatory requirements, sponsor SOPs, and approved study protocols.

As part of a leading global Contract Research Organization (CRO), CRAs play a key role in site monitoring, data quality oversight, subject safety, and audit readiness across domestic and international clinical trials conducted in more than 100 countries.


About Thermo Fisher Scientific

Thermo Fisher Scientific is the world leader in serving science, with annual revenue exceeding USD 44 billion and a global workforce of over 90,000 colleagues. Through its PPD clinical research portfolio, the organization delivers laboratory, digital, decentralized, and traditional clinical trial services that help accelerate the development of life-changing therapies worldwide.


Key Responsibilities

  • Perform and coordinate all aspects of clinical monitoring and site management from study start-up through close-out.

  • Conduct on-site and remote monitoring visits to assess protocol compliance, subject safety, and data integrity.

  • Apply Risk-Based Monitoring (RBM) principles, including root cause analysis (RCA) and corrective/preventive action (CAPA) development.

  • Ensure data accuracy through source data review (SDR), source data verification (SDV), and CRF review.

  • Review investigational product accountability, including physical inventory and documentation.

  • Prepare and submit monitoring visit reports, follow-up letters, and documentation in accordance with SOPs and timelines.

  • Escalate site issues and protocol deviations to clinical management and ensure timely resolution.

  • Support investigator site initiation, ongoing site management, and trial close-out activities.

  • Maintain Trial Master File (TMF) and essential documents in compliance with ICH-GCP and regulatory requirements.

  • Update clinical trial systems such as CTMS according to study conventions.

  • Facilitate effective communication between investigative sites, sponsors, and internal project teams.

  • Participate in audits, inspections, investigator meetings, and project initiatives as required.


Experience Requirements (By Level)

  • CRA I:

    • Minimum 2 years of onsite clinical monitoring experience

    • Exposure to ICH-GCP, SOPs, and basic monitoring activities

  • CRA II:

    • Typically 3–5 years of independent clinical monitoring experience

    • Strong experience in RBM, SDV/SDR, site issue management, and trial oversight

  • Senior CRA:

    • Typically 5+ years of clinical monitoring experience

    • Demonstrated leadership in site management, mentoring junior CRAs, and complex trial execution


Education Requirements

  • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related discipline
    OR

  • Registered Nursing (RN) qualification or equivalent relevant academic/vocational training

Equivalent combinations of education, training, and experience may be considered.


Required Skills and Competencies

  • Strong clinical monitoring and site management expertise

  • Solid understanding of medical terminology, therapeutic areas, and clinical trial processes

  • Working knowledge of ICH-GCP, regulatory requirements, and sponsor SOPs

  • Proficiency in Risk-Based Monitoring concepts and issue resolution

  • Excellent analytical, critical thinking, and problem-solving skills

  • Strong written and verbal communication skills in English

  • Effective interpersonal and stakeholder management skills

  • High attention to detail and strong organizational abilities

  • Ability to work independently and collaboratively in cross-functional teams

  • Proficiency in Microsoft Office and ability to learn clinical trial systems

  • Valid driver’s license where applicable


Work Environment & Travel

  • Office-based and clinical site environments

  • Exposure to standard healthcare and laboratory settings

  • Ability to work under pressure while managing multiple priorities

  • Independent travel may be required, including local and domestic travel by road, rail, or air, based on project needs


Career Growth & Development

CRAs at Thermo Fisher Scientific benefit from structured career pathways, continuous learning, and exposure to global clinical programs. Opportunities include advancement within Clinical Operations, leadership roles, or specialized tracks based on performance, expertise, and business needs.