Job Description
As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What You’ll Be Doing:
- Serve as the primary liaison between investigational sites and the sponsor, with a strong focus on the unique requirements of early-phase clinical trials
- Conduct all types of monitoring visits (pre-study, site initiation, interim, and close-out) with an emphasis on complex, first-in-human (FIH), dose-escalation, and pharmacokinetic/pharmacodynamic (PK/PD) studies
- Ensure site compliance with ICH-GCP, protocol requirements, SOPs, and regulatory guidelines, particularly in the context of early-phase safety and data integrity
- Maintain accurate and timely documentation within CTMS and eTMF systems, adhering to Early Development data capture and reporting standards
- Closely monitor subject safety during dose escalation and sentinel dosing periods; ensure prompt and accurate AE/SAE/PQC reporting and follow-up
- Support subject identification and enrollment in specialized patient populations or healthy volunteer studies, as applicable
- Oversee investigational product accountability, storage, and handling, with attention to early-phase-specific requirements
- Collaborate across cross-functional teams including CTAs, Clinical Trial Managers (CTMs), Local Trial Managers (LTMs), Pharmacovigilance, and Clinical Pharmacology to ensure successful execution of early-phase protocols
You Are:
- Located in the U. S. Central/Southeast Region , with easy access to a major airport to support regional travel
- A graduate with a B Sc., R.N., or equivalent degree , ideally in Biological Sciences or a related field
- An experienced CRA with 1. 5–2 years of on-site monitoring experience in industry-sponsored clinical trials
- Well-versed in Oncology Early Development , with 2+ years of Phase I/II monitoring experience
- Comfortable managing the complexities of First-in-Human (FIH) and dose-escalation trials
- Familiar with or experienced in risk-based monitoring methodologies
- Proactive in supporting patient recruitment and retention strategies at your sites
- An effective partner to investigators and site staff , committed to meeting study timelines
- Tech-savvy, with working knowledge of CTMS, EDC, eTMF, IWRS , and safety reporting systems
- A strong communicator and influencer , skilled at managing relationships both remotely and on-site
- A self-starter and team player , who thrives working independently and collaboratively
- Knowledgeable in ICH-GCP and U. S. regulatory guidelines
- Willing to travel up 40-50% of the time within the Midwest/Central United States – preference for candidates who reside in Illinois, Missouri, Tennessee, Texas, Michigan, Kentucky, Florida, Georgia or North Carolina
- Legally authorized to work in the U.S. without the need for future visa sponsorship
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:
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.
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.
Job Tags
Remote job, Permanent employment, Interim role, Self employment, Local area, Visa sponsorship, Flexible hours,