Clinical Research Associate - Start up - Cross TA

ICON plc • Chicago, IL

8d • $91,336 - $114,170 • Onsite

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.

Requirements

• Must have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
• Must be located in the Illinois; near a major airport.
• 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
• 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.
• Have an 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.

Nice To Haves

• Analytical/risk-based monitoring experience is an asset

Responsibilities

• 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.

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