Clinical Research Associate – Start up

🔥 20 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $91.3k - $114.2k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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.

🎯 Requirements

• 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 • 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

• 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