Sr CRA I (Oncology/Ophthalmology) – Remote (India)
Company: Syneos Health
Location: Remote – India
Job ID: 25102625
Updated: November 5, 2025
✅ About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization supporting Clinical Development, Medical Affairs, and Commercial operations.
29,000 employees across 110 countries
Worked with 94% of FDA-approved Novel Drugs and 95% of EMA-authorized Products
Supported 200+ studies, 73,000 sites, and 675,000+ trial patients
Syneos builds an environment focused on innovation, diversity, learning, career growth, and Total Self culture.
✅ Role Summary
The Senior Clinical Research Associate I (Sr CRA I) is responsible for on-site and remote clinical monitoring activities across Oncology and Ophthalmology studies.
The role ensures compliance with ICH-GCP, regulatory requirements, protocol adherence, subject safety, and data integrity.
✅ Core Responsibilities
1. Site Monitoring & Compliance
Conduct site qualification, initiation, interim monitoring, and close-out visits (remote or on-site).
Evaluate site performance and ensure compliance with:
ICH-GCP
Protocol
Regulatory guidelines
Company SOPs
Identify risks, protocol deviations, and escalate critical issues to the project team.
Review informed consent documentation for completeness and accuracy.
2. Data Verification & Review
Perform Source Document Review (SDR) and Source Data Verification (SDV).
Review CRFs and verify that clinical data entered is accurate and complete.
Use query resolution techniques to ensure timely closure.
Ensure site compliance with electronic data capture systems.
3. Investigational Product (IP) Management
Conduct IP inventory and reconciliation.
Verify IP dispensing and administration as per protocol.
Review IP storage, security, and temperature monitoring logs.
Ensure proper labeling, import, release, and return processes.
4. Documentation & Reporting
Maintain and update:
Confirmation letters
Follow-up letters
Trip reports
Communication logs
Tracking systems
Ensure Investigator Site File (ISF) is accurate and reconciled with the Trial Master File (TMF).
5. Site Support & Study Oversight
Support site recruitment and patient retention strategies.
Provide guidance to site teams on study processes.
Ensure all site-level project staff are trained on protocol and regulatory requirements.
Attend Investigator Meetings and training sessions.
6. Cross-Functional Collaboration
Act as primary liaison with site personnel and Central Monitoring Associates.
Coordinate with study teams to meet project timelines, deliverables, and quality targets.
Participate in project team meetings and monitoring discussions.
7. Audit Readiness
Support site preparedness for audits and inspections.
Implement corrective actions where necessary.
8. Leadership & Mentorship
Mentor and train junior CRAs.
Conduct sign-off visits for new CRA staff when assigned.
May be assigned Clinical Operations Lead (COL) tasks under supervision.
✅ Additional Responsibilities – RWLP (Real World Late Phase)
For RWLP projects, the Sr CRA I is titled Sr Site Management Associate I, and responsibilities include:
End-to-end site support (identification ➝ close-out)
Understanding local requirements for late-phase, observational, and real-world studies
Chart abstraction & real-world data collection
Relationship building with sponsors, medical liaisons, and local affiliates
Developing country-level informed consent forms
Participating in bid defense meetings
Identifying operational efficiencies & process improvements
✅ Qualifications
Bachelor’s degree or RN in a life science or related field
Strong knowledge of ICH-GCP and regulatory guidelines
Proficient in clinical trial technologies (EDC, CTMS, eTMF)
Strong communication, interpersonal, and presentation skills
Basic critical thinking and problem-solving capability
Ability to travel up to 75%
✅ Role Category & Impact
Individual contributor role with developing subject matter expertise
May guide up to 2 junior staff
Responsible for entire site processes or defined project components
In-depth functional knowledge of clinical monitoring and site management
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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Bangor | Brewer |New Jersey :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
Renfrew | Mississauga | North York | Australia | Richmond Hill | Uxbridge |Canada :
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Argentina | Peru |Brazil :
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Auckland |New Zealand :
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Madrid |Cebu Province :
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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 :
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Rho |Jakarta :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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New Mexico | Ciudad de México |Dubai :
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Najran | Rabigh | Riyadh | Khulais | Jeddah | King Abdullah Economic City |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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