Clinical Research Associate II

Regulatory Toolkit; Dallas (TX); On-site; USD 70,000 - 95,000; Full time

Job summary

ICON Strategic Solutions is seeking a Clinical Research Associate (Cross Therapeutic Area) for Dallas, TX. You will act as the primary liaison between investigational sites and the sponsor, performing site visits and ensuring ICH-GCP compliance across multiple therapeutic areas.

Travel up to 50% is expected, with preference for candidates in Dallas area. The role requires a Life Sciences degree or RN, 2+ years of on-site monitoring experience in pharma/CRO, and proficiency with CTMS/eTMF.

Qualifications

• Bachelor’s degree in Life Sciences or RN
• Eligible to work in United States without visa sponsorship
• 2+ years of on-site monitoring experience in pharma/CRO
• Experience across multiple therapeutic areas
• Proficient in ICH-GCP, local regulatory requirements, CTMS and eTMF
• Clear communicator, problem-solver and collaborative team player
• Willing to travel up to 50% for on-site monitoring visits; Dallas area preferred

Responsibilities

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct 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 and AE/SAE/PQC reporting
• Support subject recruitment and retention at the site level
• Oversee drug accountability and storage, return or destruction
• Resolve data queries and drive 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 CTAs, LTMs, and CTMs

Skills

On-site monitoring

ICH-GCP

CTMS

eTMF

Cross-therapeutic experience

Travel up to 50%

Team collaboration

Education

Bachelor’s degree in Life Sciences

Registered Nurse (RN)

Tools

CTMS

eTMF

Job description

Clinical Research Associate - Cross Therapeutic Area - Dallas

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 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 50% for on-site monitoring visits across south region; preference given to candidates residing in Dallas, Texas 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.

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.