Title: Clinical Research Associate (CRA) – Level I, II, and Senior
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research – Monitoring / Site Management
Company Overview:
Thermo Fisher Scientific is a global leader in clinical research services, driving innovation to bring life-changing therapies to patients worldwide. Our PPD® clinical research portfolio delivers comprehensive trial support across commercial and government contracts, spanning start-up, monitoring, and close-out activities. Join a team dedicated to high-quality, cost-efficient clinical studies and operational excellence.
Role Overview:
The Clinical Research Associate (CRA) is responsible for monitoring investigator sites to ensure compliance with protocols, ICH-GCP guidelines, regulatory requirements, and SOPs. The CRA role encompasses risk-based monitoring, data verification, site management, and communication with cross-functional teams. Positions are available for Level I, Level II, and Senior CRA based on experience and responsibilities.
Key Responsibilities:
Site Monitoring & Management
Conduct remote or on-site monitoring visits to assess protocol compliance, data accuracy, and adherence to regulatory requirements.
Perform source data verification (SDV), case report form (CRF) review, and investigational product accountability.
Implement risk-based monitoring strategies, including root cause analysis and corrective/preventive actions.
Maintain audit readiness by ensuring required essential documents are complete and updated.
Project Coordination & Communication
Maintain regular communication with investigative sites between visits to ensure protocol adherence and issue resolution.
Escalate observed deficiencies and follow through on resolution with clinical management.
Participate in investigator meetings and site initiation visits, ensuring site readiness and compliance.
Update clinical trial management systems with site activities, trial status, and progress reports.
Quality Assurance & Compliance
Ensure trials are conducted per protocol, ICH-GCP, applicable regulations, and sponsor guidelines.
Conduct site file reviews and ensure regulatory documentation is accurate and complete.
Contribute to process improvements, SOP adherence, and standard business practices.
Qualifications & Experience:
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field; Registered Nurse certification is an advantage.
2+ years of experience as an on-site clinical research monitor (CRA Level I). Experience for Level II/Sr. CRA roles as per organizational requirements.
Valid driver’s license (where applicable) and ability to travel independently.
Skills & Competencies:
Strong clinical monitoring and medical/therapeutic knowledge.
Working knowledge of ICH-GCP, regulatory guidelines, and protocol adherence.
Critical thinking, problem-solving, and risk-based monitoring expertise.
Excellent written, verbal, and presentation skills in English.
Proficient in Microsoft Office and clinical trial management systems.
Ability to manage multiple priorities, work independently, and adapt to diverse environments.
Strong organizational, interpersonal, and team collaboration skills.
Work Environment:
Independent travel up to XX% (automobiles, airplanes, trains) may be required.
Ability to work upright and stationary during monitoring visits, in office and non-traditional settings.
Exposure to laboratory or healthcare environments may occur.
Why Join Us:
Engage in meaningful work supporting patient safety and drug development globally.
Work remotely with cross-functional clinical teams while maintaining professional growth.
Contribute to high-impact clinical research programs with a leading global CRO.
Apply Today: Advance your clinical research career with Thermo Fisher Scientific and make a tangible impact on global healthcare outcomes.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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 :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Birmingham |Virginia :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
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Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
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Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
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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Zaventem |South America :
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Athens | Koropi |Greece :
Greece |North Island :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Bangkok |Israel :
Netanya | Tel Aviv | Yavne | Kfar Saba | Be'Er Sheva |Remote :
Hungary | McFarland | Faridabad | Thailand | French | Castlebar | Nairobi | Lousiana | Manipal | Green Way | Leinster | Hammond | Remote, USA | Melbourne | Switzerland | Minnesota | Remote | Zaragoza | Belgium | Medan | Blue Bell | Remote - Africa | Riga | Texas | Remote - South America (Latin Americal) | Victoria | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Springville | Tulsa | Lenexa | Bountiful | Bishop | Ireland | Remote - Middle East | Slovakia | Xzagreb |Republic of Colombia :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
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