Remote CRA II / Senior CRA
syneoshealth · HRV-Remote
Opis radnog mjesta
About the role
Syneos Health is seeking a remote Clinical Research Associate (CRA II) or Senior CRA to monitor clinical trial sites, ensure compliance with regulatory standards, and support the successful execution of studies.
Key responsibilities
- Perform remote and on‑site monitoring activities including site qualification, initiation, interim monitoring, and close‑out visits.
- Review source documents, verify data entry in case report forms, and resolve queries within agreed timelines.
- Assess site performance, manage investigational product inventory, and ensure adherence to ICH‑GCP and protocol requirements.
- Collaborate with site teams to implement risk‑based monitoring tools and improve trial quality.
- Document activities through trip reports, communication logs, and other required project documentation.
Required profile
- Bachelor’s degree or RN in a related field, or equivalent education and experience.
- Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
- Ability to work independently, adapt to changing priorities, and communicate effectively with site personnel.
Required skills
- Good Clinical Practice (GCP) compliance
- ICH guideline familiarity
- Electronic Data Capture (EDC) systems
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syneoshealth
HRV-Remote
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