Clinical Research Associate

07 set - Milano
Opis

We are looking for a motivated Clinical Research professional to join our Clinical Operations team. This role is designed for someone with a scientific/life sciences degree and initial experience in clinical research, such as a Clinical Trial Assistant (CTA), Clinical Research Coordinator, Study Coordinator or similar position, who is looking to develop their career into a CRA role.

The successful candidate will initially work as a non-certified CRA, receiving the required induction and clinical research training, including the CRA course where applicable. Once the required training and CRA certification have been successfully completed, the role will progress into a CRA position, with responsibility for monitoring clinical studies.

Key responsibilities:
- Support the planning, set-up and conduct of clinical studies, primarily observational studies and clinical investigations.
- Support site identification, selection, initiation and close-out activities.
- Develop knowledge and practical experience in clinical trial monitoring under the supervision of a Project Manager.




- Support on-site and remote monitoring activities in accordance with study protocols, SOPs, ICH-GCP and applicable regulations.
- Maintain communication with investigators and site staff and follow up on study-related queries and activities.
- Review and maintain essential study documentation, Investigator Files and TMF/eTMF.
- Support regulatory and ethics submissions by coordinating required documentation.
- Monitor study timelines, recruitment, site performance and key study metrics.
- Support the identification and follow-up of protocol deviations and other study issues.
- Prepare study documentation, visit reports and follow-up communications.
- Participate in Sponsor, Investigator and Monitor meetings as required.
- Complete all required training and maintain accurate study, time and expense records.
- Maintain confidentiality and ensure compliance with applicable regulations, SOPs and quali

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