Clinical Research Associate (CRA) – Level II
Remote, India
Work Type: Full-time
Job ID: R-01326248
Work Environment: Fully Onsite
Work Schedule: Standard (Monday–Friday)
Environmental Conditions: Office
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.
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.
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.
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.
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.
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.
Collaborate with project teams on issue resolution.
Share process improvement ideas.
Assist in developing trial publications/tools.
Maintain accurate timesheets and expense reports.
Bachelor’s degree in a life science or nursing field
OR
Registered Nursing certification with relevant qualifications
Minimum 2+ years of on-site clinical research monitoring
Valid driver’s license (as applicable)
Equivalent combinations of education and experience will be considered
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
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
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
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
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Rostock |Munich :
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Swords |Dún Laoghaire :
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China | Quarry Bay |Hubei :
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Dalian |Republic of China :
Beijing |Shanghai Sai :
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Hangzhou |Melbourne :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
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Montreal |Chile :
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Croatia |Zagreb :
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Prague |Republic of Egypt :
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Turku |France :
Paris | Lyon |Attica :
Koropi | Athens |Greece :
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Jakarta |Israel :
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Rho |Japan :
Japan | Saitama |Tokyo :
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Almaty |Remote Korea :
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Sweden |Taipei :
Taipei |Williamson :
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