Senior Clinical Research Associate, (Contract, Hungary) - IQVIA Biotech
Job description ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study. Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities. Trains site staff on the EDC system and verifies site computer system. Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS. Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports. Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required. Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries. May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA. Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested. At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at .
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