Clinical Research Associate II (CRA II)
PRA Health Sciences
Req #: 118908
Type: Bulgaria
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Overview: As a Clinical Research Associate II you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: We are currently looking to recruit an experience CRA II who would be interested to work in a sponsor dedicated role. Responsibilities * Conducts monitoring activities using different methods, e.g., both on-site and remote, where allowed by country regulations. * Conducts Source Document Review and Source Data Verification of appropriate site source documents and medical records * Verifies required clinical data entered in the case report form (CRF) is accurate and complete. * Manages reporting of protocol deviations and appropriate follow-up. * 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. * Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. * Manages reporting of identified issues and manages follow-up to resolution. * Documents activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Study Monitoring Plan. * Ensures all activities are managed by site personnel who are appropriately delegated and trained. * Check the site/external facilities, equipment and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable) * Check site-specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, Investigational Product Accountability Log). * Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical Qualifications: Requirements: * Bachelor's degree or RN in a related field or equivalent combination of education, training and experience * Proficiency in local language preferred. English is required * A minimum of 3 years' experience as a clinical monitor with demonstrated experience of virtual and onsite monitoring * Demonstrated experience to manage complex and high risk protocols * Previous experience in monitoring protiocols in oncology, internal medicine and/or hear failure What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. #LI-DS1 #LI-Hybrid
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