Clinical Research Associate - Start up - Cross TA

IRE • Chicago, IL

7d • Remote

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. This role focuses on multiple trials within Cross Therapeutic areas with a start-up focus.

Requirements

• Minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
• Must be located in Illinois; near a major airport.
• 2 - 3 years’ experience in monitoring pharmaceutical industry clinical trials
• 1 - 3 years' experience monitoring cross therapeutic area clinical trials
• Knowledge of several therapeutic areas
• Study start up experience as a CRA
• 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.
• In-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
• 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.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

• Analytical/risk-based monitoring experience is an asset

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree