Senior Trial Monitor - Como (CO) - beBeeClinicalResearchAssociate

    beBeeClinicalResearchAssociate
    beBeeClinicalResearchAssociate Como (CO)

    3 giorni fa

    A tempo pieno

    Titolo del lavoro: Senior Clinical Research Associate

    Descrizione

    Job Title:
    Senior Clinical Research Associate Position Summary


    The Senior Clinical Research Associate (CRA) is responsible for conducting on-site and remote monitoring visits in accordance with applicable regulatory standards. The CRA must be able to identify issues, present findings to site staff, provide retraining if needed, and communicate findings to the study team via escalation of issues or within the monitoring visit report.


    Culture and Values


    • Customer Experience – Representing a company in a customer-facing position is a tremendous responsibility and opportunity.
    • Continuous Improvement - Demonstrates initiative and critical thinking to identify process gaps. Develops solutions to deliver improving results.
    • Culture And Values - Exemplifies company values ensuring an open climate engaging ethically legally compliant strives work across boundaries complex matrix environment leads participate promotional materials internally cross-functionally ensure processed completely based accurate clinical data practice interpretation PRINCIPAL RESPONSIBILITIES Conducts works cooperatively scheduling escalates evaluates prepares monitors completes professional accurately reports documents compliance regulatory safety local requirements processes procedures analyzes query response actions logs follows protocols department WIs SOP guidelines MDR ISO 14155 ICH GCP implements files documentation necessary conducts follow-up reviews resolution retrain interacts staff sites Data Safety Results Markers Management Team utilizes resource enhances quality timeline ongoing organization learns communicates Medical Affairs Sales Administrative departments receives regular manage eCRF completion queries assists develops calls FAQs other documents QUALIFICATIONS / EXPERIENCE REQUIREMENTS Bachelor higher-level degree life sciences nursing health related disciplines comparable qualification Knowledge medical device sector minimum years experience onsite research as CRA industry CRO High attention detail organizational paired excellent people skills prior Vascular Interventional Cardiology Peripheral Vascular Intervention advantage SPECIALIZED SKILLS & OTHER REQUIREMENTS Strong knowledge understanding ability apply MDR ISO 14155 ICH GCP guidelines governing clinical trials demonstrated aptitude relevant therapeutic areas learn integrate new specialized training mentor personnel perform monitor independent regional area minimal supervision proficient medical terminology effective time management organizational excel writing oral communication interpersonal experienced spreadsheets databases applications MS Word Excel independently part Teleflex systems reasonable home office setting dedicated desk space accommodate work responsibilities supplied equipment
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