Clinical Research Associate II

Regulatory Toolkit; Chicago (IL); Sur place; USD 91 000 - 114 000; Plein temps

Avantages offerts par ce poste

Health and wellbeing programmes

Retirement and pension plans

Life assurance

Employee assistance programmes and wel

Learning and development opportunities

Career progression opportunities

Résumé du poste

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. This Clinical Research Associate role in Chicago requires a 2+ year on-site monitoring track record in pharma or CRO and strong ICH-GCP knowledge.

You will maintain CTMS/eTMF documentation, support site training, monitor safety reporting, and help with site budgeting and payments.

Qualifications

• Bachelor's in Life Sciences or RN with licensure.
• 2+ years of on-site monitoring in pharma/CRO.
• Strong ICH-GCP knowledge and regulatory awareness.
• Willingness to travel 60-75% across the Midwest.

Responsabilités

• Serve as primary point of contact between investigational sites and sponsor.
• Conduct site visits including selection, initiation, 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 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.
• Collaborate with cross-functional partners including CTAs, LTMs, and CTMs.

Connaissances

On-site monitoring

Communication

Problem solving

Team collaboration

Travel willingness

Formation

Bachelor's degree in Life Sciences or equivalent

Qualified RN

Outils

CTMS

eTMF

Description du poste

Clinical Research Associate - Cross Therapeutic - Chicago

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 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 Midwest region; preference given to candidates residing in Chicago 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.

Salary Range $91,336.00-$114,170.00