Clinical Research Associate II (CRA II)
Company: ICON plc
Location: Bangalore, India (Office with Flex)
Role Location: Mumbai (As mentioned in the job description)
Employment Type: Full-Time
Experience Required: Minimum 3 Years
Salary Package
Expected CTC: ₹10 LPA – ₹16 LPA (Estimated market range based on experience, therapeutic area expertise, and organization. Actual salary may vary.)
Job Summary
ICON is seeking an experienced Clinical Research Associate II (CRA II) to manage and monitor clinical trials while ensuring patient safety, protocol compliance, and data integrity. The role involves site monitoring, collaboration with investigators, and supporting the successful execution of clinical studies in accordance with ICH-GCP and regulatory requirements.
Key Responsibilities
Conduct site qualification, site initiation, routine monitoring, and close-out visits for clinical trials.
Ensure compliance with study protocols, ICH-GCP guidelines, and applicable regulatory requirements.
Monitor patient safety, data quality, and protocol adherence throughout the study.
Collaborate with investigators, site personnel, and cross-functional teams to support efficient study execution.
Perform source data verification (SDV), data review, and query resolution to maintain high-quality clinical data.
Review and contribute to study documentation, including clinical protocols, monitoring reports, and Clinical Study Reports (CSRs).
Ensure timely reporting of site findings and follow-up on corrective and preventive actions.
Maintain accurate trial documentation in compliance with regulatory and sponsor requirements.
Support successful inspection readiness and audit compliance.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or another healthcare-related field.
Minimum 3 years of experience as a Clinical Research Associate with on-site monitoring experience.
Strong knowledge of clinical trial processes, ICH-GCP guidelines, and applicable regulatory requirements.
Prior or current experience in at least one of the following therapeutic areas:
Oncology
Immunology
Gastroenterology
Pulmonology
Required Skills
Clinical trial monitoring and site management.
Site qualification, initiation, monitoring, and close-out activities.
Strong understanding of ICH-GCP and global clinical research regulations.
Source Data Verification (SDV) and clinical data review.
Protocol compliance and patient safety management.
Excellent organizational and documentation skills.
Strong verbal and written communication.
Ability to work independently and collaboratively in a fast-paced environment.
Willingness to travel at least 60% for domestic and international site visits.
Valid driver's license.
Employee Benefits
Competitive base salary.
Performance-based incentives.
Medical, dental, and vision insurance (where applicable).
Retirement and pension plans.
Life insurance and disability coverage.
Employee Assistance Program (EAP).
Health and wellbeing initiatives.
Structured learning and professional development programs.
Career advancement opportunities within a global clinical research organization.
Preferred Candidate Profile
Experience managing multiple clinical trial sites.
Strong problem-solving and stakeholder management skills.
Ability to deliver high-quality monitoring activities within study timelines.
Experience working in global or multinational clinical trials.
Commitment to quality, compliance, and patient-focused clinical research.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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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 | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Hilo | Honolulu |Tennessee :
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Lisbon | Oeiras | Portugal |WI :
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Oklahoma City |Puerto Rico :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Germany | GErmany |Lower Saxony :
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Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
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 :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
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 :
Richmond Hill | Uxbridge | North York | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Be'Er Sheva | Netanya | Tel Aviv | Kfar Saba | Yavne |Remote :
Remote - South America (Latin Americal) | Minnesota | Ireland | Tulsa | Remote - Europe | Springville | McFarland | Hungary | Zaragoza | French | Melbourne | Lousiana | Hammond | Slovakia | Manipal | Belgium | Leinster | Perth | Green Way | Remote - Africa | Riga | Nairobi | Castlebar | Blue Bell | Xzagreb | Faridabad | Milwaukee | Medan | Texas | Bountiful | Thailand | Remote - Middle East | Bishop | Victoria | Lenexa | Regulatory Labeling Manager (NA and LATAM Only) | Switzerland |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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