Job Title: Senior Clinical Research Associate (Sponsor Dedicated)
Specialization: Immunology & Rare Diseases
Location: Not Specified
Job Type: Full-Time
About Syneos Health
Syneos Health is a global biopharmaceutical solutions organization committed to accelerating customer success. With a focus on clinical, medical affairs, and commercial insights, Syneos Health simplifies processes to deliver therapies that change lives. With 29,000 employees across 110 countries, Syneos Health drives innovation to meet evolving healthcare needs.
Key Responsibilities
Site Monitoring & Compliance
Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).
Ensure compliance with ICH-GCP, regulatory requirements, and protocols.
Verify informed consent processes, subject safety, and data integrity at sites.
Clinical Data Management
Perform Source Document Review (SDR) and Source Data Verification (SDV) to ensure accuracy and completeness.
Resolve data queries and guide site staff on query resolution.
Investigational Product (IP) Oversight
Manage inventory, reconciliation, and compliance of IP administration.
Ensure adherence to GCP and local regulations for IP handling and storage.
Documentation & Reporting
Maintain records such as confirmation letters, trip reports, and communication logs.
Support subject recruitment and ensure adherence to the Trial Master File (TMF) and Investigator Site File (ISF) requirements.
Training & Collaboration
Mentor junior CRAs and conduct training visits, as required.
Collaborate with internal teams and sponsors to ensure project deliverables are met.
Participate in Investigator Meetings, team meetings, and training sessions.
Audit Readiness
Provide site-level guidance to meet audit readiness standards.
Additional Real-World Late Phase (RWLP) Responsibilities
Support site activities from identification to close-out.
Develop country-specific informed consent forms and contribute to regulatory updates.
Perform chart abstraction and data collection for real-world study designs.
Identify operational improvements and suggest process enhancements.
Qualifications
Education: Bachelor's degree or RN in a related field, or equivalent combination of education and experience.
Experience: Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other regulatory requirements.
Skills: Proficient in computer applications, excellent communication, and critical thinking abilities.
Travel: Willingness to travel up to 75% regularly.
Why Join Syneos Health?
Work on groundbreaking studies with 94% of FDA-approved drugs in the last 5 years.
Participate in a Total Self Culture fostering authenticity and inclusivity.
Enjoy professional growth through training, recognition programs, and mentorship.
Collaborate with a diverse, global team dedicated to improving patient outcomes.
Additional Information
Tasks and responsibilities may be adjusted based on project needs.
Syneos Health is committed to diversity, inclusion, and compliance with the Americans with Disabilities Act (ADA), providing reasonable accommodations as required.
Explore an opportunity to grow your career in clinical research with Syneos Health and make a difference in the world of healthcare.
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Ranchi |Sikkim :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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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 :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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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 :
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Sheffield |Oxfordshire :
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Tallinn |Hà Nội :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
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Prague |Chile :
Santiago |Bosnia and Herzegovina :
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