Clinical Research Coordinator I

Position Overview

The Clinical Research Coordinator I (CRC I) role at Insight Hospital and Medical Center in Chicago involves supporting clinical trial activities under the guidance of senior research coordinators and leadership. This position is full-time, based on-site, with working hours from Monday to Friday, 8AM to 5PM. It reports to the Director of Clinical Trials and the CRC III Team Lead.

Core Competencies

• Basic understanding of clinical trial procedures, GCP principles, FDA regulations, and IRB compliance.
• Highly organized with an eye for detail, capable of managing multiple tasks under supervision.
• Strong communication and interpersonal skills to interact effectively with participants and the research team.
• Committed to safeguarding participant safety, ensuring data accuracy, and following regulatory standards.
• A motivated learner willing to adapt and develop within a dynamic research environment.
• Experience using electronic health record systems; familiarity with electronic data capture and clinical trial management software is advantageous.

Key Responsibilities

• Assist in coordinating clinical study activities including site preparation, participant recruitment, enrollment, and follow-ups with oversight from senior staff and investigators.
• Ensure adherence to study protocols, accurate and prompt data documentation, and readiness for monitoring audits and sponsor evaluations.
• Function as a primary contact for participants, providing study education, obtaining informed consent in compliance with ICH-GCP and IRB guidelines, and supporting community outreach and recruitment efforts.
• Collect and maintain clinical trial data with attention to confidentiality, enter information into electronic systems timely, and assist in resolving data queries.
• Support preparation and submission of regulatory documents (IRB applications, amendments, safety reports) and help maintain essential regulatory files and overall study documentation.
• Participate in quality assurance activities and assist with corrective action implementations while ensuring compliance with institutional policies and guidelines.

Qualifications and Experience

• Preferred: Bachelor’s degree in life sciences, nursing, healthcare, or related fields; associate degree with relevant experience also considered.
• 0-1 year of experience in clinical, research, or healthcare settings.
• Eligibility for clinical research certification (e.g., CCRC, CCRP) with expectation to complete certification within 18 months of hire.
• Willingness to learn about clinical trial operations and regulatory frameworks.
• Strong organization and multitasking capabilities combined with effective communication skills.
• Proficient in electronic health record systems; familiarity with electronic data capture and clinical trial management platforms is preferred.
• Phlebotomy skills considered a plus.
• Ability to work independently and as part of a team in a fast-paced environment; professional references may be requested.