Clinical Research Associate
Hobson Prior are currently looking for a Clinical Research Associate to join a Global CRO in Paris on a permanent basis. This role will perform site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely).
Please note that to be considered for this role you must have the right to work in this location.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Accountable to use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
- Per the Clinical Monitoring/Site Management Plan: Assesses site processes, Conducts Source Document Review of appropriate site source documents and medical records, Verifies required clinical data entered in the case report form is accurate and complete, Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines , Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture and Verifies site compliance with electronic data capture requirements
- Routinely reviews the Investigator Site File for accuracy, timeliness and completeness.
- 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.
- May perform investigational product inventory, reconciliation and reviews storage and security.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
- Partakes in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
- Any other assigned duties.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation and interpersonal skills.
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
- A minimum of 2 years' experience as CRA.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Ability to manage required 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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