Job detail

Clinical Research Associate

ICON plc

#Monitoring #Life Sciences #CRO #Pharmaceutical #Oncology #ICH-GCP #Clinical Research Associate #eTMF #CTMS #Regulatory compliance #Data entry #Risk management

Full Time Remote Ok Remote friendly 2-5 yrsPosted 1 month ago

Location (2)

Blue Bell, South Dakota

Locations

2 listed locations

Blue Bell, South DakotaTexas

Quick overview

The Clinical Research Associate serves as the primary point of contact for investigational sites, ensuring compliance with ICH-GCP and regulatory standards. They are responsible for conducting site visits, monitoring patient safety, managing documentation, and overseeing drug accountability.

Requirements summary

Candidates must hold a Bachelor’s degree in Life Sciences or be a qualified RN with at least 2 years of on-site monitoring experience. Proficiency in Oncology trials and the ability to travel up to 50% within the region are required.

bachelor degreeCommunicationProblem-solvingOncologyeTMFCTMSRegulatory complianceTeam collaborationICH-GCPPatient safetyClinical monitoringSite managementSite recruitmentAE/SAE reporting

Job description

Clinical Research Associate - Oncology - Texas 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 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 monitoring Oncology trials ideally in Heme/ONC 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 Texas near major HUB airports to support efficient regional travel 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 maximize 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 site to read more about the benefits ICON offers.
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, color, 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 or submit a request here.
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.
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

2 listed locations

Quick overview

Requirements summary

Job description

Benefits

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