Clinical Research Associate I/ II / Senior

ICON; Downers Grove (IL); Remote; USD 60,000 - 90,000; Full time

Job summary

ICON, a leading healthcare intelligence organization, is looking for a Clinical Research Associate to oversee site operations in clinical studies. The role includes monitoring, training personnel, and building partnerships with sites to ensure compliance and enhance patient enrollment. Candidates should have a university degree and a minimum of one year of monitoring experience, as well as strong attention to detail and communication skills.

Qualifications

• Minimum 1 year of independent on-site monitoring experience.
• Fluent in English and local language (both written and oral).
• Knowledge of ICH-GCP Guidelines.

Responsibilities

• Initiate, monitor, and close sites in clinical studies.
• Manage assigned study sites, conducting Phase I-IV protocols.
• Provide ongoing training for amendments and new site personnel.

Skills

Attention to detail

Record-keeping

Communication

Education

University Degree

Job description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Responsibilities:

• Initiate, monitor, and close sites in clinical studies in compliance with sponsor procedures, ICH-GCP guidelines, and local regulations, ensuring site commitments are met.
• Act as the frontline liaison between the sponsor and sites to ensure successful collaboration, meeting milestones and deliverables with ownership mindset.
• Manage assigned study sites, conducting Phase I-IV protocols according to monitoring plans and sponsor procedures.
• Perform Site Initiation Visits, ensuring site personnel are fully trained on trial aspects.
• Provide ongoing training for amendments and new site personnel, re-training as needed.
• Conduct continuous site monitoring activities (onsite and remote), ensuring protocol compliance and regulatory adherence.
• Engage early with sites regarding patient inventory and flow, collaborating with global and local study teams.
• Perform Site Closeout activities per SOPs and regulations, informing sites of follow-up and archiving requirements.
• Build strong partnerships with sites to enhance patient enrollment and issue resolution.
• Participate in audit and inspection readiness activities, implementing corrective actions timely.
• Collaborate with internal stakeholders and site staff to resolve data queries and ensure timely data entry.
• Maintain up-to-date Investigator Files and essential documents, managing sTMFs.

Qualifications:

• University Degree
• Minimum 1 year of independent on-site monitoring experience
• Ability to travel nationally with overnight stays
• Experience with all types of Monitoring Visits (Site Selection, Initiation, Routine, Close Out)
• Knowledge of ICH-GCP Guidelines
• Excellent record-keeping and attention to detail
• Fluent in English and local language (both written and oral)

Visit our careers website to learn more about working at ICON. We are committed to an inclusive, accessible workplace free of discrimination. For accommodations during the application process, please visit this link. We encourage you to apply even if you don’t meet all requirements, as we value diverse experiences and potential.

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