Clinical Research Associate II

ICON Strategic Solutions; Orlando (FL); In loco; USD 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

ICON Strategic Solutions in Orlando, FL is seeking a Clinical Research Associate to support cross-therapeutic site monitoring. You will act as liaison between sites and sponsor, ensure GCP compliance, and maintain CTMS/eTMF records.

The role requires 2+ years of on-site monitoring in pharma/CRO, a Life Sciences degree or RN, and willingness to travel up to 60–75% across the southeast region, with Orlando as a hub.

Competenze

• Bachelor's degree in Life Sciences or RN qualification.
• 2+ years of on-site monitoring experience in pharma/CRO.
• Proficient with ICH-GCP and regulatory requirements.
• Willingness to travel up to 60–75% in the southeast region.

Mansioni

• Serve as primary point of contact between investigational sites and sponsor.
• Conduct site visits: selection, initiation, routine monitoring, and close-out.
• Ensure site compliance with ICH-GCP, SOPs, and regulations.
• Maintain CTMS and eTMF documentation.
• Support site staff training and maintain compliance records.
• Monitor patient safety and report AE/SAE/PQC promptly.
• Support subject recruitment and retention at site level.
• Oversee drug accountability and storage, return or destruction.
• Resolve data queries and drive timely data entry.
• Document site progress and escalate risks to clinical team.

Conoscenze

On-site monitoring

ICH-GCP knowledge

Effective communication

Travel readiness

Formazione

Bachelor's degree in Life Sciences

Registered Nurse (RN)

Strumenti

CTMS

eTMF

Descrizione del lavoro

Clinical Research Associate - Cross Therapeutic Area - Orlando, FL

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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 elevate 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 across multiple therapeutic areas
• 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 60% - 75% for on-site monitoring visits across southeast region; preference given to candidates residing in Orlando, FL 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.

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