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.
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Siliguri |Illinois :
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