Clinical Research Associate II

ICON plc • Orlando, FL

7d

About The Position

Clinical Research Associate II supporting cross-therapeutic-area studies in a sponsor-dedicated model at ICON Strategic Solutions. The role serves as the primary contact between investigational sites and the sponsor, conducts site monitoring activities, and supports compliance, patient safety, data quality, and site operations. The position involves regional on-site monitoring travel across the Southeast, with preference for candidates based in Orlando, Florida near a major hub airport.

Requirements

• Bachelor’s degree in Life Sciences or equivalent, or qualification as a registered nurse.
• Eligible to work in the United States without visa sponsorship.
• At least 2 years of on-site monitoring experience in the pharmaceutical or CRO industry.
• Experience monitoring across multiple therapeutic areas.
• Proficiency in ICH-GCP, local regulatory requirements, and clinical systems such as CTMS and eTMF.
• Clear communication, problem-solving, and collaboration skills.
• Willingness and ability to travel up to 60%–75% for on-site monitoring visits across the Southeast.

Nice To Haves

• Residence in Orlando, Florida, near a major hub airport to support efficient regional travel.

Responsibilities

• Serve as the primary point of contact between investigational sites and the sponsor.
• Conduct site selection, initiation, routine monitoring, and close-out visits.
• Ensure site compliance with ICH-GCP, SOPs, and applicable regulations.
• Maintain current documentation in CTMS and eTMF systems.
• Support and track site staff training and maintain compliance records.
• Monitor patient safety and ensure timely, accurate AE/SAE/PQC reporting.
• Support subject recruitment and retention at the site level.
• Oversee drug accountability and ensure proper storage, return, or destruction.
• Resolve data queries and promote timely, high-quality data entry.
• Document site progress and escalate risks or issues to the clinical team.
• Assist with tracking site budgets and ensuring timely site payments, as applicable.
• Collaborate with cross-functional partners, including CTAs, LTMs, and CTMs.

Benefits

• Competitive base salary and performance-related incentives.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level