Clinical Research Associate (CRA) – Level I, II & Senior CRA
Location: Remote / India (Fully Onsite when required)
Job ID: R-01326248
Employment Type: Full-time
Work Schedule: Standard (Monday–Friday)
Category: Clinical Research / Remote
About the Company
Thermo Fisher Scientific is a global leader in clinical research services, enabling the development and delivery of life-changing therapies worldwide. Our Clinical Research team, powering the PPD® clinical research portfolio, provides end-to-end support for clinical trials across therapeutic areas, ensuring high-quality, cost-effective, and timely study execution.
With operations in over 100 countries, Thermo Fisher combines scientific rigor, innovative technology, and regulatory expertise to help sponsors advance clinical programs efficiently while maintaining patient safety and data integrity.
Role Overview
As a Clinical Research Associate (CRA) – Level I, II, or Senior CRA, you will oversee clinical trial monitoring and site management activities to ensure studies are conducted in compliance with protocol, ICH-GCP guidelines, and regulatory requirements. You will perform on-site and remote monitoring visits, maintain study documentation, and act as a critical liaison between investigative sites, sponsors, and project teams.
This role emphasizes risk-based monitoring, data accuracy, and audit readiness, while fostering collaborative relationships with investigative sites and internal teams.
Key Responsibilities
Perform and coordinate all aspects of clinical trial monitoring and site management.
Conduct on-site and remote visits to assess protocol compliance, regulatory adherence, and study documentation accuracy.
Monitor investigational product handling, CRFs, and source data verification (SDV/SDR).
Identify site deficiencies, perform root cause analysis, and implement corrective and preventive actions.
Facilitate effective communication between investigative sites, sponsors, and internal project teams.
Ensure all essential documents are complete and audit-ready, maintaining regulatory and GCP compliance.
Support risk-based monitoring initiatives, assessing site performance and implementing mitigation strategies.
Participate in investigator meetings, site selection, study initiation, and trial close-out activities.
Provide timely reporting on study status, findings, and corrective actions to Clinical Team Managers (CTMs).
Maintain study systems, trial tracking, and documentation per company and sponsor standards.
Contribute to process improvement initiatives, training, and development of project tools.
Required Qualifications and Experience
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent vocational qualification.
Registered Nursing certification is acceptable for clinical monitoring equivalency.
Experience
CRA Level I: Minimum 2 years of clinical research monitoring or relevant site management experience.
CRA Level II: Minimum 3–5 years of clinical trial monitoring experience.
Senior CRA: 5+ years of clinical monitoring experience with leadership exposure on complex studies.
Proven understanding of ICH-GCP, Indian regulatory requirements, and sponsor-specific SOPs.
Experience in risk-based monitoring, clinical trial documentation, and study close-out processes.
Skills and Competencies
Strong clinical monitoring and site management skills.
In-depth knowledge of medical/therapeutic areas and clinical trial terminology.
Effective root cause analysis, critical thinking, and problem-solving capabilities.
Excellent organizational, time management, and multitasking skills.
Strong written and verbal communication skills in English; presentation skills preferred.
Ability to work independently or as part of a global, cross-functional team.
Proficiency in Microsoft Office and clinical trial management systems (CTMS/EDC).
Flexibility to travel independently up to 30–50% of the time as required by study protocols.
Work Environment
Ability to perform monitoring visits in non-traditional or field-based environments.
Exposure to healthcare or laboratory settings as part of clinical trial activities.
Work under pressure while managing multiple priorities and study requirements.
Remote work capability with occasional on-site presence based on study needs.
What We Offer
Opportunities to work on global clinical trials with life-changing therapies.
Exposure to advanced monitoring strategies including decentralized and risk-based monitoring.
Inclusive and collaborative work culture fostering professional growth.
Training and development programs to advance clinical research expertise.
Apply Now
Advance your clinical research career with Thermo Fisher Scientific. Join a leading global CRO, contribute to high-quality clinical trials, and help bring innovative therapies to patients worldwide.
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Netherlands |Remote Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
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Montreal |Brussels :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Prague |Chile :
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