PICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. /ppbr/ppbThe Field CRA /b is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines. /ppbr/ppWe are currently looking for a Clinical Research Associate to join one of our Sponsor-dedicated teams. /ppbr/ppbPrincipal Responsibilities: /b /pulliAct as liaison between the in-house team, vendors, and multiple clinical sites. /liliDevelop strong site relationships, maintaining close contact with sites by telephone, correspondence, and remote and on-site visits. /liliApply SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, other study materials as applicable. /liliHelp identify and qualify potential investigators. Perform Pre-Study Site Visits. /liliAssist with start-up activities, including essential document review and collection as requested. /liliPerform Site Initiation Visits, Interim Monitoring Visits, Close Out visits as assigned. /liliProvide initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements. /liliMonitor site compliance with study protocol and GCP. /liliPerform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP. /liliEnsure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines. /liliPerform drug accountability and ensure adequate drug supply. /liliReview research specimen sample documentation, storage and processing, and ensure shipments are sent to central lab as required. /liliAssist study team as necessary in resolving lab queries and other issues. /liliCollaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements. /liliEnsure adequacy of clinical supplies to the site. /liliCollect and review site essential documents and ensure site regulatory files are complete and accurate. /liliMonitor site compliance with IRB policies/processes and ensure timely reporting, submissions, and approvals. /liliTrack and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance. /liliPrepare and complete visit trip reports, confirmation and follow up letters within timelines outlined in the CMP. /liliTrack, report, and follow all action items to resolution. /liliMaintain CTMS in a timely fashion, utilizing available reports and study tools. /liliWork proactively with sites to address site issues and action items to obtain swift resolution and escalate to PL/PI per CMP. /liliAssist data management as required. /liliProvide co-monitoring support as requested or as necessary to develop additional skills /li /ulpbr/ppbQualifications: /b /pulliMinimum of 2-3 years of independent monitoring experience is mandatory. /liliA minimum of a Masters degree is required. A degree in a health or science related field is preferred /liliProficient in speaking and writing in Italian and English. /liliValid drivers license /liliKnowledge of and ability to apply CFR and GCP/ICH is required. Experience on global clinical trials is preferred. /liliProficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint (preferred). Previous experience with EDC and CTMS systems. /liliRequires effective organizational and time management skills. /liliAble to manage multiple and varied tasks with enthusiasm under limited direction and on own initiative. Ability to prioritize workload with attention to detail. /liliStrong communication and interpersonal skills. /liliAbility to discuss scientific, medical and therapeutic area information within small and large groups of medical professionals. /liliTravel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location. /liliResponsive and proactive, a team player. /li /ulpbr/ppbWhat ICON can offer you: /b /ppbr/ppOur 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. /ppbr/ppIn 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. /ppbr/ppOur benefits examples include: /pulliVarious annual leave entitlements /liliA range of health insurance offerings to suit you and your family’s needs /liliCompetitive retirement planning offerings to maximise savings and plan with confidence for the years ahead /liliGlobal 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 /liliLife assurance /liliFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others /li /ulpbr/ppVisit our careers website to read more about the benefits of working at ICON: /ppbr/ppAt 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. /ppbr/p pbr/ppInterested 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. /p