CRC - Clinical Research Coordinator at Revival Research Institute, LLC in Elgin, IL

Job description

• This is not an entry-level position. We are hiring an experienced site-based coordinator who has independently run industry-sponsored interventional trials and can take ownership of assigned protocols from site initiation visit through close-out.
• Clinical Research Coordinators at Revival coordinate and manage multiple concurrent studies and support the Investigators and clinical staff with study-related tasks including, but not limited to:

Responsibilities

• Screening, recruitment, and enrollment. Pre-screen candidates against inclusion/exclusion criteria, independently obtain informed consent on interventional protocols in accordance with ICH-GCP and 21 CFR Part 50, and conduct study visits per protocol. Collect, process, and ship research specimens, including IATA-regulated shipments, where applicable.
• Data and monitoring. Obtain, review, and maintain source documents contemporaneously. Enter data into EDC within sponsor-specified timelines and resolve queries within guidelines provided in the protocol. Host monitoring visits, and drive CRA findings and follow-up letters through to resolution.
• Regulatory and quality. Own the organization and completeness of all trial-related documents and correspondence across regulatory binders and eRegulatory systems. Implement and maintain quality control and assurance methods at the study level, and maintain inspection-ready files at all times.
• Sponsor and IRB communication. Serve as day-to-day point of contact for sponsors, CRAs, central labs, and IRT/IWRS vendors. Independently prepare and submit regulatory documents including amendments, continuing reviews, adverse and serious adverse event reports within required reporting windows, and protocol deviation reports.
• Investigational product accountability. Manage IP receipt, dispensing, reconciliation, storage conditions, and temperature excursion documentation in accordance with the protocol and sponsor requirements.
• Professional and technical knowledge. Maintain current working knowledge of ICH-GCP E6(R3), applicable FDA regulations, and evolving sponsor and site practices. Maintain certification and required training.
• Participant communication and confidentiality. Communicate with research participants and their families throughout the study lifecycle, support retention across visit schedules, and protect participant confidentiality in accordance with HIPAA.

Requirements

• 2+ years as a Clinical Research Coordinator at a research site, serving as primary coordinator on industry-sponsored interventional trials. Academic-only, registry-only, or observational/minimal-risk experience does not meet this requirement.
• 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, as well as IV certification, is preferred.
• Proficiency in conducting physical assessments, including comfort with vital signs and 12-lead ECG acquisition.
• Master's degree in a health-related field, or equivalent clinical research site experience.
• Strong computer proficiency including Microsoft Office (Word, Excel, Outlook); excellent verbal and written communication; ability to work independently, manage competing protocol deadlines, and assume ownership of assigned studies.
• Ability to work on-site in Elgin, Illinois.

Skills

Required

• Clinical research coordination
• EDC platforms
• Hosting monitoring visits
• ICH-GCP E6(R3)
• 21 CFR Parts 11, 50, 54, 56, and 312
• HIPAA
• Phlebotomy
• Microsoft Office (Word, Excel, Outlook)
• Verbal and written communication
• Independent work
• Time management
• Ownership of studies

Preferred

• IV certification