Clinical Research Associate
ICON Strategic Solutions · Georgia, United States
- Hybrid
- Full-time
- $90,000 / year
- Georgia, United States
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Job highlights
- Monitor oncology clinical trials at investigational sites.
- Ensure site compliance with GCP and regulations.
- Manage site documentation and data integrity.
- Support subject recruitment and patient safety.
- Travel up to 50% in the Southeast region.
About the role
Clinical Research Associate - Oncology
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 hematology oncology clinical trials
- 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 Georgia, Florida or North Carolina, 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Key skills/competency
- Clinical Research Associate
- Oncology Trials
- Site Monitoring
- ICH-GCP
- CTMS
- eTMF
- Regulatory Requirements
- Patient Safety
- Data Management
- Cross-functional Collaboration
Skills & topics
- Clinical Research Associate
- Oncology
- Clinical Trials
- Site Monitoring
- ICH-GCP
- CTMS
- eTMF
- CRO
- Pharmaceutical
- Healthcare
How to get hired
- Tailor your resume: Highlight your 2+ years of on-site monitoring experience, especially in oncology trials, and proficiency in ICH-GCP and clinical systems.
- Showcase your skills: Emphasize your communication, problem-solving, and collaborative abilities in your application and during interviews.
- Address travel willingness: Clearly state your ability and willingness to travel up to 50% in the Southeast region, mentioning proximity to major airports if applicable.
- Research ICON: Understand ICON's commitment to inclusion, innovation, and their mission in clinical research to align your responses with their values.
- Apply strategically: If unsure about meeting all requirements, still apply and express your enthusiasm for the role and ICON.
Technical preparation
Review ICH-GCP guidelines thoroughly.,Practice using CTMS and eTMF systems.,Study oncology clinical trial protocols.,Understand AE/SAE/PQC reporting procedures.
Behavioral questions
Describe a challenging site monitoring experience.,How do you ensure patient safety and data integrity?,How do you handle disagreements with site staff?,Tell me about a time you improved site compliance.
Frequently asked questions
- What are the key responsibilities for an Oncology Clinical Research Associate at ICON?
- As an Oncology Clinical Research Associate at ICON, you will be the main contact for investigational sites, conduct various site visits, ensure compliance with ICH-GCP and regulations, maintain CTMS and eTMF systems, monitor patient safety, and support subject recruitment. You will also resolve data queries and collaborate with internal teams.
- What qualifications are required for this Clinical Research Associate role at ICON?
- ICON requires a Bachelor's degree in Life Sciences or equivalent, or a qualified RN. You need at least 2 years of on-site monitoring experience in pharma or CRO, specifically with hematology oncology trials, and proficiency in ICH-GCP, local regulations, and clinical systems like CTMS and eTMF. Eligibility to work in the US without sponsorship is also necessary.
- Is there travel involved for the Oncology Clinical Research Associate position at ICON?
- Yes, this role requires travel up to 50% for on-site monitoring visits across the Southeast region. Preference is given to candidates residing in Georgia, Florida, or North Carolina, ideally near major HUB airports to facilitate efficient regional travel.
- What kind of benefits does ICON offer its Clinical Research Associates?
- ICON offers a competitive salary and a comprehensive benefits package designed for well-being and work-life balance. This includes various annual leave entitlements, health insurance, retirement planning, a global employee assistance program (LifeWorks), life assurance, and flexible country-specific optional benefits like childcare vouchers and discounted gym memberships.
- How does ICON support diversity and inclusion for job applicants?
- ICON is fundamentally committed to inclusion and belonging, fostering a diverse culture that rewards high performance. They are dedicated to providing an inclusive and accessible environment for all candidates and ensure equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
- What should I do if I don't meet every requirement for the Clinical Research Associate job at ICON?
- ICON strongly encourages you to apply even if you don't meet every single requirement. They believe there's a high chance you might be exactly what they're looking for, whether for this specific role or other opportunities within ICON. Your unique skills and potential are valued.