
CRA II
2 weeks ago
As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. We are looking for an Oncology CRA in the Northeast Region
Responsibilities
- Manage all aspects of site evaluation, initiation, monitoring, and close-out for 3 studies across 10–12 sites.
- Ensure trial conduct adheres to ICH GCP, FDA regulations, SOPs, and protocol requirements.
- Train and retrain site personnel on study protocols, systems, and operational procedures.
- Monitor and document adverse event and serious adverse event reporting to ensure patient safety.
- Collaborate with sites to develop and execute recruitment strategies to meet enrollment targets.
- Ensure data integrity through EDC oversight, timely query resolution, and support of database lock.
- Maintain audit-ready documentation and reconcile with the Trial Master File.
- Monitor investigational product and non-clinical supply management.
- Identify and resolve site performance, quality, or compliance issues with effective intervention plans.
- Serve as the primary liaison between site personnel and sponsor study teams, ensuring seamless communication and oversight.
You Are
- Hold a Bachelor’s degree in Life Sciences or be a Registered Nurse (RN).
- A Clinical Research Associate with a minimum of 2 years of on-site monitoring experience in Oncology, specifically solid tumor trials for a pharmaceutical company or CRO.
- Experienced with Graft-Versus-Host Disease (GVHD) studies.
- Based on the West Coast (PST), able to conduct regional travel up to 8–10 days per month.
- Must have a valid driver’s license and the ability to travel regularly.
- Comfortable working in a dedicated FSP model supporting one sponsor.
- Proficient in EDC, CTMS, IVRS, and Microsoft Office Suite.
- Knowledgeable in ICH GCP, HIPAA, FDA CFR, and other applicable guidelines.
- A strong communicator with excellent time management, attention to detail, and problem-solving skills.
- Able to work independently and collaboratively within a matrix team environment.
Pay Range ($91,336/yr USD – $114,170/yr USD)
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.
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: careers.iconplc.com/benefits
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. this statement may be adjusted per policy.
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.
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