An exciting opportunity has arisen for a Senior Clinical Research Associate in Italy. You will be expected to perform site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits.
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
- Maintains 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.
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
- Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Skills and Requirements
- 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
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.
- Ability to manage
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