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Hobson Prior are currently looking for a CRA II to join a Global CRO at their offices in Paris on a contract basis. This position will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites.
- Accountable to complete site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice and protocol compliance.
- Uses 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.
- Demonstrates diligence in protecting the confidentiality of each subject/patient.
- Upholds a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
-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
-Verifies site compliance with electronic data capture requirement
- Regularly reviews the Investigator Site File for accuracy, timeliness and completeness.
- Reconciles contents of the ISF with the Trial Master File.
- You will ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Any other assigned duties.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Strong communication, presentation and interpersonal skills.
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
- 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, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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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