We are currently seeking CRA I to join our team in Hungary. This role will be home based.
WHAT YOU WILL DO
You will utilize your skills knowledge and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
Key responsibilities:
Independently manage and monitor clinical trial sites in line with ICHGCP applicable regulations Fortrea SOPs and study protocols (including initiation routine monitoring and closeout visits).
Ensure subject safety protocol compliance and data integrity through thorough source data verification eCRF review query management and oversight of informed consent processes.
Maintain inspectionready sites by ensuring completeness and accuracy of site regulatory documentation eTMF and investigational product accountability.
Collaborate closely with study teams to deliver milestones on time support audit readiness and address site issues proactively.
Requirements
University or college degree or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
Six (6) months of clinical monitoring experience
Basic understanding of Regulatory Guidelines
Ability to work within a project team
Good planning organization and problem-solving skills
Good computer skills with good working knowledge of a range of computer packages
Works efficiently and effectively in a matrix environment
Valid Drivers License
Fluency in English as well as in Hungarian
Learn more about our EEO & Accommodations request here.
Required Experience:
IC
We are currently seeking CRA I to join our team in Hungary. This role will be home based. WHAT YOU WILL DOYou will utilize your skills knowledge and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical resea...
We are currently seeking CRA I to join our team in Hungary. This role will be home based.
WHAT YOU WILL DO
You will utilize your skills knowledge and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
Key responsibilities:
Independently manage and monitor clinical trial sites in line with ICHGCP applicable regulations Fortrea SOPs and study protocols (including initiation routine monitoring and closeout visits).
Ensure subject safety protocol compliance and data integrity through thorough source data verification eCRF review query management and oversight of informed consent processes.
Maintain inspectionready sites by ensuring completeness and accuracy of site regulatory documentation eTMF and investigational product accountability.
Collaborate closely with study teams to deliver milestones on time support audit readiness and address site issues proactively.
Requirements
University or college degree or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
Six (6) months of clinical monitoring experience
Basic understanding of Regulatory Guidelines
Ability to work within a project team
Good planning organization and problem-solving skills
Good computer skills with good working knowledge of a range of computer packages
Works efficiently and effectively in a matrix environment
Valid Drivers License
Fluency in English as well as in Hungarian
Learn more about our EEO & Accommodations request here.
Required Experience:
IC
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