Summary

ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services, operating as a specialized division of ICON plc. As the world's largest FSP provider with over 90 partnerships globally and more than 14,000 dedicated employees, the company offers embedded clinical research expertise within pharmaceutical and biotechnology organizations. ICON Strategic Solutions delivers comprehensive FSP models that provide cost-savings, clinical expertise, and significantly improve business performance for sponsors. The company specializes in deploying dedicated teams across all major clinical development functions including clinical monitoring, project management, data management, statistical programming, pharmacovigilance, and regulatory affairs. With headquarters in Dublin, Ireland and operations spanning multiple global locations, ICON Strategic Solutions enables pharmaceutical and biotech companies to access specialized talent and operational excellence while maintaining flexibility in their clinical development programs. The organization focuses on delivering innovative clinical research solutions that accelerate drug development timelines and enhance the quality of clinical trial execution across therapeutic areas including oncology, cardiovascular diseases, central nervous system disorders, and rare diseases.

Job description

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 escalate 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 northwest region; preference given to candidates residing in Pacific NW, Utah, or Northern California near major HUB airports to support efficient regional travel

Requirements

Bachelor’s degree in Life Sciences or equivalent, or a qualified RN
Eligible to work in United States without visa sponsorship
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
Clear communicator, problem-solver, and collaborative team player
Willing and able to travel up to 50% for on-site monitoring visits across northwest region

Benefits

Annual leave
Health insurance
Retirement planning
Global Employee Assistance Programme
Life assurance
Childcare vouchers
Bike purchase schemes
Discounted gym memberships
Subsidized travel passes
Health assessments

Company overview

ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services, operating as a specialized division of ICON plc. As the world's largest FSP provider with over 90 partnerships globally and more than 14,000 dedicated employees, the company offers embedded clinical research expertise within pharmaceutical and biotechnology organizations. ICON Strategic Solutions delivers comprehensive FSP models that provide cost-savings, clinical expertise, and significantly improve business performance for sponsors. The company specializes in deploying dedicated teams across all major clinical development functions including clinical monitoring, project management, data management, statistical programming, pharmacovigilance, and regulatory affairs. With headquarters in Dublin, Ireland and operations spanning multiple global locations, ICON Strategic Solutions enables pharmaceutical and biotech companies to access specialized talent and operational excellence while maintaining flexibility in their clinical development programs. The organization focuses on delivering innovative clinical research solutions that accelerate drug development timelines and enhance the quality of clinical trial execution across therapeutic areas including oncology, cardiovascular diseases, central nervous system disorders, and rare diseases.