Job detail

Clinical Research Associate

ICON plc

#Regulatory Requirements #Patient Safety #Life Sciences #CRO #Clinical Development #Site Initiation #Immunology #Pharmaceuticals #ICH-GCP

Quick overview

Serve as the primary contact between investigational sites and sponsors while conducting various site visits to ensure compliance with ICH-GCP and SOPs. Responsibilities include monitoring patient safety, overseeing drug accountability, and managing data entry and site documentation.

Requirements summary

Requires a Bachelor's degree in Life Sciences or a qualified RN with at least 2 years of on-site monitoring experience in the pharmaceutical or CRO industry. Candidates must be eligible to work in the US without sponsorship and be willing to travel up to 50% across the southeast region.

bachelor degreeRegulatory ComplianceSite MonitoringClinical Trial ManagementSubject RecruitmenteTMFCTMSData Query ResolutionPatient Safety MonitoringICH-GCPDrug Accountability

Job description

Clinical Research Associate - Cross Therapeutic Area - Miami ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
What You Will Be Doing: Serve as the primary point of contact between investigational sites and the sponsor Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out Ensure site compliance with ICH-GCP, SOPs, and regulations Maintain up-to-date documentation in CTMS and eTMF systems Support and track site staff training and maintain compliance records Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting Support subject recruitment and retention efforts at the site level Oversee drug accountability and ensure proper storage, return, or destruction Resolve data queries and drive timely, high-quality data entry Document site progress and escalate risks or issues to the clinical team Assist in tracking site budgets and ensuring timely site payments (as applicable) Collaborate with cross-functional partners including CTAs, LTMs, and CTMs You are: A graduate with a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN Eligible to work in United States without visa sponsorship A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry Experienced across multiple therapeutic areas, including Immunology preferred.
Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF A clear communicator, problem-solver, and collaborative team player Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in Miami, FL near major HUB airports to support efficient regional travel Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility ICON is an equal opportunity employer.
We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee?
Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide.
You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live.
If you’re as driven as we are, join us.
You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
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Clinical Research Associate

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Quick overview

Requirements summary

Job description

Benefits

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