Clinical Research Associate II - Sponsor-Dedicated, Remote (Slovakia)
syneoshealth · SVK-Remote
Job description
About the role
Syneos Health is hiring a CRA II for a sponsor-dedicated, remote position based in Slovakia. The role covers site qualification, initiation, interim monitoring, site management and close-out, ensuring regulatory, ICH-GCP and protocol compliance. For Real World Late Phase studies, the title used is Site Management Associate II.
Key responsibilities
- Perform site qualification, initiation, interim monitoring, site management and close-out visits, on-site or remotely, and escalate serious issues to the project team
- Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
- Review source documents and CRFs, resolve queries and verify electronic data capture compliance
- Check investigational product inventory, dispensing and administration, and ensure proper labelling, import and release
- Review the Investigator Site File and reconcile it with the Trial Master File
- Document activities, support recruitment and retention, and enter data into tracking systems
- Act as liaison with sites, prepare for investigator meetings and support audit readiness
- Support site support throughout the study lifecycle, chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons and local country staff
Required profile
- Bachelor's degree or RN in a related field, or equivalent education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements
- Ability to manage travel of up to 75% regularly
- Excellent communication, presentation and interpersonal skills
Required skills
- Good computer skills and willingness to adopt new technologies
- ICH-GCP knowledge
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Published 6 hours ago
Expires 1 month from now
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syneoshealth
SVK-Remote
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