Job Title:
CRA II / Sr CRA I (Client-based, Oncology)
Location: Mumbai, India (Client-based)
Job ID: 25101933
Updated: September 17, 2025
Company Overview – Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success through clinical, medical affairs, and commercial insights.
Key Highlights:
Operates in 110 countries with 29,000 employees.
Partnered with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, 200+ studies, 73,000 sites, and 675,000+ trial patients in the past 5 years.
Promotes career development, technical training, peer recognition, and a Total Self culture.
Role Summary
CRA II / Sr CRA I is responsible for monitoring clinical research studies, ensuring regulatory compliance, protocol adherence, and data integrity. The role involves on-site and remote monitoring, site management, and risk-based monitoring in therapeutic areas like Oncology, Hematology, Cardiology, Neuropsychiatry, Rare Diseases, and Immunology.
Key Responsibilities
Site Monitoring & Management:
Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).
Assess site staff performance, escalate serious issues, and develop corrective action plans.
Verify informed consent and ensure subject/patient confidentiality.
Clinical Data Oversight:
Source document review, CRF data verification, and query resolution.
Ensure electronic data capture compliance and accurate reporting of investigational product (IP) administration.
Maintain Investigator Site File (ISF) and reconcile with Trial Master File (TMF).
Project Coordination:
Document activities via trip reports, follow-up letters, and communication logs.
Track observations, status, and action items in tracking systems.
Prepare for investigator meetings and sponsor interactions.
Support audit readiness and follow-up actions.
Real-World / Late Phase Studies:
Support site identification through close-out, including chart abstraction and data collection.
Collaborate with sponsor affiliates, medical science liaisons, and local staff.
Train junior staff and identify out-of-scope activities.
Compliance & Guidelines:
Maintain working knowledge of ICH/GCP Guidelines, regulatory requirements, and SOPs.
Complete project-specific training and adhere to company processes.
Qualifications & Skills
Education: Bachelor’s degree or RN in a related field (Pharma background preferred).
Experience: Minimum 3–5 years of clinical monitoring experience, preferably in Oncology or related therapeutic areas.
Skills:
Knowledge of GCP/ICH Guidelines and applicable regulatory requirements.
Strong computer literacy and adaptability to new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to travel up to 75% regularly.
Additional Information
Tasks and responsibilities are not exhaustive; additional duties may be assigned.
Equivalent experience may be considered in lieu of formal qualifications.
Nothing in this description constitutes an employment contract.
Syneos Health complies with ADA and applicable local regulations.
How to Apply
Apply via the Syneos Health website.
Not ready to apply? Join the Talent Network to stay connected for future opportunities.
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Swords |Dún Laoghaire :
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China | Quarry Bay |Hubei :
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Beijing |Shanghai Sai :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
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Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
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Lyon | Paris |Attica :
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Japan | Saitama |Tokyo :
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Warsaw |Remote :
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Riyadh | Najran | Jeddah | Rabigh | King Abdullah Economic City | Khulais |Nišava District :
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Brazil | Sao paulo |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
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Taipei |Williamson :
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