Summary

ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.

Job description

What will you be doing?

Works on multiple trials within the Cross Therapeutic areas - Start up focus
Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.
Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies.
Build strong relationships with site personnel to facilitate a smooth onboarding process.
Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs).
Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation.
Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process.
Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities.
Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones.
Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.
Proactively identify and address any issues that may delay study initiation or affect trial deliverables.
Maintain precise documentation to ensure readiness for inspections.
Support sites during the activation phase until they achieve “Green Light” status for site opening.
Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met.
Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards.

What do you need to have?

Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
Preferred location is Nashville, TN ; near a major airport. TN/KY near major hub acceptable.
Must have 2 -3 years’ experience in monitoring pharmaceutical industry clinical trials
Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials
Analytical/risk-based monitoring experience is an asset
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet all of our study timelines
Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

Requirements

Minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
2-3 years’ experience in monitoring pharmaceutical industry clinical trials
Minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials
Analytical/risk-based monitoring experience is an asset
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet all of our study timelines
Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting)
Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face
Strong team member and self-starter with the ability to work independently
Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

Benefits

Medical, Dental & Vision
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes
Wellbeing resources
Learning and development opportunities

Company overview

ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.