Overview
ICON 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.
The Field CRA 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.
We are currently looking for a Clinical Research Associate to join one of our Sponsor-dedicated teams.
Responsibilities
* Act as liaison between the in-house team, vendors, and multiple clinical sites. Develop strong site relationships, maintaining close contact with sites by telephone, correspondence, and remote and on-site visits.
* Apply SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, and other study materials as applicable. Identify and qualify potential investigators. Perform Pre-Study Site Visits. Assist with start-up activities, including essential document review and collection as requested.
* Perform Site Initiation Visits, Interim Monitoring Visits, and Close Out visits as assigned. Provide initial and ongoing training to clinical investigators and site staff regarding the study protocol, procedures, documentation, and regulatory requirements.
* Monitor site compliance with study protocol and GCP. Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP. Ensure data entry adherence to CRF Completion Guidelines, deadlines, and query resolution.
* Perform drug accountability and ensure adequate drug supply. Review research specimen documentation, storage and processing, and coordinate shipments to the central lab as required. Resolve lab queries with the study team as needed.
* Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements. Ensure adequacy of clinical supplies to the site. Collect and review site essential documents and maintain complete and accurate regulatory files.
* Monitor site compliance with IRB policies and processes, ensuring timely reporting, submissions, and approvals. Track and report study progress, data monitoring, protocol variations, issue resolution, and follow-up compliance.
* Prepare and complete visit trip reports, confirmations, and follow-up letters within CMP timelines. Track, report, and resolve action items. Maintain CTMS using available reports and study tools.
* Work proactively with sites to address issues and escalate to PL / PI per CMP. Provide data management assistance as required. Provide co-monitoring support as requested to develop additional skills.
Qualifications
* Minimum of 2-3 years of independent monitoring experience. A minimum of a Masters degree is required; a degree in a health or science-related field is preferred.
* Proficient in speaking and writing in Italian and English. Valid driver’s license. Knowledge of CFR and GCP / ICH requirements. Experience on global clinical trials is preferred.
* Proficiency with Microsoft Office products (Word, Excel, PowerPoint, SharePoint preferred). Previous experience with EDC and CTMS systems. Strong organizational and time management skills; ability to manage multiple tasks with limited direction and initiative. Ability to prioritize workload with attention to detail. Strong communication and interpersonal skills. Ability to discuss scientific, medical, and therapeutic area information with groups of medical professionals.
* Travel requirements will vary depending on study requirements, site assignments, and location. Responsive, proactive, and a team player.
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; Global Employee Assistance Programme with 24-hour access to a global network of professionals; life assurance; flexible country-specific optional benefits (e.g., childcare vouchers, bike purchase schemes, gym discounts, subsidised travel passes, health assessments, among others).
Visit our careers website to read more about the benefits of working at ICON. 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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please let us know through the form below.
If you’re unsure whether you meet all the requirements, we encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for at ICON, whether for this role or others.
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