CRA II / Senior CRA I (Oncology)
Company: Syneos Health
Location: Mumbai, India (Client Office-Based)
Department: Clinical Operations / Clinical Monitoring
Job Type: Full-Time
JOB OVERVIEW
The CRA II / Senior CRA I is responsible for monitoring and managing oncology clinical trial sites throughout the study lifecycle, ensuring compliance with ICH-GCP, regulatory requirements, sponsor protocols, and company SOPs. The role includes site qualification, initiation, routine monitoring, close-out visits, source data verification, investigational product accountability, site management, patient safety oversight, and collaboration with sponsors and cross-functional teams to ensure successful execution of oncology clinical trials.
KEY RESPONSIBILITIES
Site Monitoring & Management
Perform Site Qualification Visits (SQV).
Conduct Site Initiation Visits (SIV).
Perform Interim Monitoring Visits (IMV).
Conduct Close-Out Visits (COV).
Manage assigned investigator sites throughout the study lifecycle.
Evaluate site performance and compliance.
Develop site-specific corrective action plans.
Escalate critical issues to project teams.
Clinical Trial Monitoring
Monitor oncology clinical studies in accordance with protocol.
Ensure compliance with ICH-GCP and regulatory requirements.
Assess protocol adherence and site processes.
Verify investigator responsibilities are fulfilled.
Support patient recruitment and retention activities.
Ensure audit readiness at study sites.
Source Data Verification (SDV)
Perform Source Document Review (SDR).
Verify Case Report Form (CRF) data accuracy.
Ensure complete and accurate clinical documentation.
Perform data quality checks.
Resolve clinical data discrepancies.
Drive timely query resolution.
Patient Safety & Compliance
Verify informed consent documentation.
Ensure patient confidentiality.
Monitor protocol deviations and violations.
Identify pharmacovigilance issues.
Escalate patient safety concerns.
Protect clinical data integrity.
Investigational Product (IP) Management
Review IP storage conditions.
Perform drug accountability.
Conduct IP reconciliation.
Verify dispensing records.
Review IP labeling and relabeling.
Ensure protocol-compliant IP handling.
Regulatory Documentation
Review Investigator Site Files (ISF).
Reconcile ISF with Trial Master File (TMF).
Maintain essential study documentation.
Ensure document completeness and accuracy.
Verify document archiving requirements.
Reporting & Documentation
Prepare monitoring visit reports.
Write confirmation and follow-up letters.
Maintain communication logs.
Update clinical tracking systems.
Document site observations and action items.
Project Coordination
Manage site-level timelines.
Support study deliverables.
Monitor project milestones.
Coordinate with project teams.
Adapt to changing project priorities.
Cross-Functional Collaboration
Act as liaison with investigator sites.
Collaborate with Central Monitoring Associates.
Participate in Investigator Meetings.
Attend sponsor meetings.
Participate in global project meetings.
Support cross-functional communication.
Audit & Inspection Readiness
Maintain inspection-ready documentation.
Support regulatory inspections.
Prepare sites for audits.
Implement follow-up corrective actions.
Training & Mentoring
Train site personnel on study requirements.
Mentor junior CRA staff when required.
Ensure compliance training completion.
Maintain knowledge of oncology clinical research standards.
Real World / Late Phase Studies (When Applicable)
Support Real World Evidence (RWE) studies.
Conduct chart abstraction activities.
Collect clinical data.
Coordinate with Medical Science Liaisons (MSLs).
Support sponsor affiliates.
Recommend potential investigator sites.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Pharmacy
Life Sciences
Biotechnology
Nursing (RN)
Biological Sciences
Related Healthcare Discipline
EXPERIENCE REQUIREMENTS
Required
Minimum 5+ years of onsite clinical monitoring experience.
Strong experience in Oncology Clinical Trials.
Experience conducting monitoring visits independently.
Experience with site management and clinical monitoring.
Ability to travel up to 75%.
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 :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
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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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Bangor | Brewer |New Jersey :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
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 :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
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 :
Ballina | Sydney |Republic of Western Australia :
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 :
Mississauga | North York | Renfrew | Richmond Hill | Australia | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
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 :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Be'Er Sheva | Tel Aviv | Kfar Saba | Netanya | Yavne |Remote :
Hammond | Lousiana | Castlebar | Victoria | Nairobi | Blue Bell | Remote - Africa | Green Way | Remote - Middle East | Zaragoza | Bishop | Medan | Faridabad | Xzagreb | Manipal | Slovakia | Switzerland | Springville | Perth | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Belgium | Melbourne | McFarland | Hungary | Lenexa | Minnesota | Bountiful | Tulsa | Leinster | French | Milwaukee | Texas | Riga | Remote - South America (Latin Americal) | Thailand | Ireland |Republic of Colombia :
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New Mexico | Ciudad de México |Dubai :
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Najran | Jeddah | Riyadh | King Abdullah Economic City | Rabigh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Singapore |Sofia City :
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Warsaw |
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