Clinical Research Associate II
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Hobson Prior are currently looking for a Clinical Research Associate II to join a Global CRO in Milan on a permanent basis.
Please note that to be considered for this role you must have the right to work in this location.
- You will act as main link with study site personnel, or in partnership with Central Monitoring Associate. Confirms all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- To prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Contributes in global clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements.
- You will execute site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice and protocol compliance.
- To confirm the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
- May perform investigational product inventory, reconciliation and reviews storage and security. Confirms the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP.
- To provide direction at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- You will maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required
- You will routinely review the Investigator Site File for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File. Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
- Excellent knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Educated in a Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, at least 2 years of experience as CRA .
- Excellent computer skills and be able to embrace new technologies.
- Excellent communication, presentation and interpersonal skills.
- Ability to travel of up to 75% on a regular basis.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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