CRA II - early development phase I/II

ICON Strategic Solutions; Missouri; On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Life insurance

Wellbeing resources

Career development

Job summary

ICON Strategic Solutions is seeking a Clinical Research Associate for Early Development with a multi-therapeutic focus. The role involves close collaboration with sponsor teams, site visits, and ensuring compliance across ICH-GCP standards.

The ideal candidate has 2+ years of on-site monitoring, a Life Sciences degree or RN, and willingness to travel up to 60% to major hub clinics. This position supports diverse early-phase studies and cross-functional partnership.

Qualifications

• Bachelor's degree in Life Sciences or RN required.
• 2+ years on-site monitoring in pharmaceutical or CRO environment.
• Willing to travel up to 60% to meet on-site monitoring expectations.

Responsibilities

• Serve as the primary point of contact between investigation sites and sponsor for early development multi-therapeutic trials.
• Conduct site visits including site selection, initiation, routine monitoring, and close-out.
• Ensure site compliance with ICH-GCP, SOPs, and local regulations.
• Maintain up-to-date documentation in CTMS and eTMF.
• Support and track site staff training and maintain compliance records.
• Monitor patient safety with timely AE/SAE/PQC reporting.
• Support recruitment and retention efforts at the site level.
• Oversee drug accountability and proper storage/destruction.
• Collaborate with cross-functional partners including CTAs, LTMs, and CTMs.

Skills

Independent monitoring experience

Phase I/II experience

Multiple therapeutic areas

Willing to travel 60%

US-based near hubs

Education

Bachelor's degree in Life Sciences or RN

Tools

CTMS

eTMF

Job description

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.

We're looking for someone with:

• 1.8+ years of independent monitoring experience
• Phase I & II / Early Development experience
• Experience across multiple therapeutic areas (non-oncology)
• Based anywhere in the U.S., preferably near a major airport/hub

A few highlights of the role:

• Oversee an average of 6 sites
• Approximately 7–8 on-site monitoring days per month, primarily at actively enrolling clinics
• Opportunity to work across diverse early phase studies in a dynamic environment

Clinical Research Associate - Early Development Multi Therapeutic - Regional (major hubs)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

What you will be doing:

• Serve as the primary point of contact between investigation sites and the sponsor for early development multi therapeutic clinical trials.
• 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 early development Phase I/II clinical studies, 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% for on-site monitoring visits; preference given to candidates residing 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.

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.

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.