Senior Clinical Research Coordinator - On-site Trials

RiseMe; Elgin (IL); On-site; USD 62,000 - 82,000; Full time

Job summary

Revival Research Institute’s site in Elgin, IL seeks an experienced Clinical Research Coordinator to independently manage interventional trials from start-up through close-out. You will screen, enroll, consent participants, and coordinate data collection and regulatory compliance.

The role requires 2+ years of site-based coordination, hands-on EDC, and strong knowledge of ICH-GCP and HIPAA. On-site work in Elgin, IL is essential; familiarity with sponsor and CRA communications is a plus.

Qualifications

• 2+ years as a Clinical Research Coordinator at a research site, primary coordinator on industry-sponsored interventional trials.
• Demonstrated experience independently obtaining informed consent on interventional protocols.
• Hands-on experience with EDC platforms.
• Demonstrated experience hosting monitoring visits and resolving monitoring findings independently.
• Working knowledge of ICH-GCP E6(R3) and 21 CFR Parts 11, 50, 54, 56, and 312, and HIPAA.
• Current phlebotomy competency, and IV certification is preferred.
• Ability to work on-site in Elgin, Illinois.

Responsibilities

• Screening, recruitment, and enrollment. Pre-screen candidates against inclusion/exclusion criteria, obtain informed consent, and conduct visits per protocol.
• Collect, process, and ship research specimens as applicable.
• Maintain source documents and enter data into EDC; support monitoring visits and resolve queries.
• Own organization and completeness of trial-related documents across regulatory binders and eRegulatory systems.
• Prepare regulatory documents for sponsors, IRB, amendments, continuing reviews, and deviation reports.
• Manage Investigational Product receipt, dispensing, reconciliation, and storage following protocol.
• Maintain knowledge of ICH-GCP E6(R3) and FDA regulations; ensure training and compliance.
• Work on-site in Elgin, Illinois with study participants and staff.

Skills

Clinical Research Coordination

Informed consent

EDC platforms

Monitoring visits

ICH-GCP E6(R3)

HIPAA

Phlebotomy (preferred)

IV certification (preferred)

MS Office

Education

Master's degree in health-related field

Tools

Microsoft Office

EDC systems

Job description

Revival Research Institute’s site in Elgin, IL seeks an experienced Clinical Research Coordinator to independently manage interventional trials from start-up through close-out. You will screen, enroll, consent participants, and coordinate data collection and regulatory compliance.

The role requires 2+ years of site-based coordination, hands-on EDC, and strong knowledge of ICH-GCP and HIPAA. On-site work in Elgin, IL is essential; familiarity with sponsor and CRA communications is a plus.