Senior Clinical Research Associate – Contractor
Location: Poland
Department: Clinical Operations
Company: Biorasi
Employment Type: Contract
Estimated Salary: €55,000 – €75,000 per year (based on experience and industry rates)
About Biorasi:
At Biorasi, we are reshaping the clinical research landscape with innovation, agility, and a global mindset. As an award-winning CRO, we empower top clinical professionals to lead transformative research. Join us in a fast-paced, collaborative culture built on scientific rigor and patient impact.
Key Responsibilities:
Site Monitoring and Management:
Plan and conduct Site Selection, Initiation, Interim Monitoring, and Close-out Visits.
Draft reports and follow-up letters for all visits.
Study Execution Oversight:
Monitor regulatory/IRB approvals, patient recruitment, CRF completion, and query resolutions.
Ensure timely delivery of investigational products, CRFs, lab kits, and study materials.
Documentation and Compliance:
Collect essential documents for eTMF filing.
Review documents for protocol adherence, safety events, and GCP compliance.
Ensure traceability and inventory checks of investigational products.
Team and Site Communication:
Train site personnel on protocols and manage ongoing communications.
Evaluate site quality and escalate non-compliance issues.
Assist in quality assurance planning and audit resolution.
Support Project Management:
Provide project updates and assist in team meetings.
Monitor site performance metrics and timelines.
Contribute to protocol and study manual reviews as needed.
Leadership & Mentoring:
Mentor CRAs and junior staff on processes and site monitoring best practices.
Lead site training or evaluation visits when required.
Candidate Requirements:
Education: Bachelor’s degree in Biomedical Sciences or related field.
Experience: Minimum 3 years of clinical monitoring experience; more preferred.
Technical Skills:
Strong command of ICH GCP and global regulatory standards.
Knowledge of MS Office (Word, Excel, PowerPoint).
Familiarity with CRF/eCRF systems and eTMF platforms.
Other Qualities:
Fluent in English and Polish (written and verbal).
Excellent planning, communication, and leadership skills.
Willingness to travel up to 70% based on project needs.
Join Us:
If you're passionate about driving clinical innovation and making a global impact, apply today at biorasi.com or contact us at careers@biorasi.com.
Gujarat :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Australia | North York | Mississauga | Richmond Hill | Uxbridge | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
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