Clinical Research Associate (CRA I / CRA II) – Clinical Research
Job ID: R-01336916
Job Type: Full-Time
Category: Clinical Research / Site Monitoring
Work Mode: Fully Remote
Location: Mumbai, Maharashtra, India
Job Overview
A leading global Contract Research Organization (CRO), part of the PPD® Clinical Research portfolio at Thermo Fisher Scientific, is hiring Clinical Research Associates (CRA I / CRA II) to support global clinical trials across multiple therapeutic areas. This role offers the opportunity to work on international studies while ensuring the highest standards of clinical trial quality, patient safety, and regulatory compliance.
As a CRA I / II, you will be responsible for overseeing assigned clinical trial sites from start-up through close-out, performing both remote and on-site monitoring activities in accordance with ICH-GCP, regulatory requirements, and client SOPs.
Key Responsibilities
Act as the primary clinical contact for assigned sites and client stakeholders
Perform on-site and remote monitoring visits in line with monitoring plans and project requirements
Conduct risk-based monitoring activities, including source data verification (SDV) and source document review (SDR)
Review clinical trial data using CTMS, EDC, IWRS, eTMF, and other clinical systems
Ensure study conduct aligns with approved protocols, ICH-GCP, SOPs, and applicable regulations
Maintain audit and inspection readiness at assigned sites
Prepare, submit, and track high-quality monitoring visit reports and follow-up letters
Collaborate with investigative sites to identify, escalate, and resolve study issues
Support site audits, regulatory inspections, and CAPA development and implementation
Maintain country-level metrics and monitoring documentation
Participate in project and client meetings and provide regular study updates
Complete all required training, timesheets, and expense reports in a timely manner
Travel to assigned sites as required by the monitoring plan (up to 60–75%)
Mentor and support junior CRAs, as applicable
Education & Experience Requirements
Postgraduate degree in Life Sciences or a related scientific discipline
Minimum 1–1.5 years of mandatory on-site clinical trial monitoring experience
Strong working knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
Experience in an FSP (Functional Service Provider) model is preferred but not mandatory
Valid driver’s license where applicable
Equivalent combinations of education, training, and relevant experience may be considered
Required Skills & Competencies
Strong site and client relationship management skills
Excellent understanding of clinical research operations and medical terminology
Proficiency in CTMS, EDC, IWRS, and eTMF platforms
Ability to interpret and adhere to client-specific SOPs and monitoring plans
Strong attention to detail with excellent documentation practices
Excellent written and verbal communication skills in English
Ability to manage multiple studies and priorities effectively
Strong problem-solving and decision-making skills
Flexibility to adapt to changing study requirements and timelines
Knowledge and application of Risk-Based Quality Management (RBQM) principles
High level of digital literacy, including Microsoft Office and clinical systems
Why Join Thermo Fisher Scientific
Work on global clinical trials across phases and therapeutic areas
Fully remote work model with extensive global exposure
Opportunity to collaborate with leading pharmaceutical and biotech sponsors
Strong focus on professional development, training, and career progression
Be part of a mission-driven organization improving patient outcomes worldwide
About Thermo Fisher Scientific
Thermo Fisher Scientific is the world leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through its PPD® Clinical Research Services, the organization supports clinical trials in over 100 countries, delivering innovation, quality, and excellence in clinical development.
Thermo Fisher Scientific is an equal opportunity employer and values diversity, equity, and inclusion across its global workforce.
Gujarat :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Cork | Dublin | Limerick | Waterford |Ulster :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 :
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Canada |Quebec :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Italy |Lombardy :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
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Santiago |Bosnia and Herzegovina :
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Sofia |Sweden :
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