Clinical Research Coordinator

OrthoIllinois•Rockford, IL

25d•Onsite

About The Position

The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and execution of clinical research studies in accordance with Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, FDA regulations, and institutional policies. This role plays a central part in subject recruitment, study documentation, protocol adherence, and maintaining regulatory compliance throughout the clinical trial lifecycle. The CRC works closely with investigators, sponsors, monitors, and research team members to ensure operational success and high-quality data collection while prioritizing patient safety and integrity.

Requirements

Bachelor's degree relevant field required
Effective written and verbal communications
Knowledge in MS Word/Excel/PowerPoint and Google apps (email, drive, calendar, excel, notepad, etc.)
Bachelor’s degree in a health-related field required (e.g., nursing, life sciences, public health, or clinical research).
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

Nice To Haves

Master’s degree in Medical Bio Technology preferred
Experience in a clinical or research setting preferred
Master’s degree in Medical Biotechnology or related field preferred.
Minimum 1 year of clinical research experience preferred (internship or externship experience acceptable for entry-level candidates with strong qualifications).
Familiarity with EDC platforms, eRegulatory systems, and ePRO is a plus.
GCP certification is preferred.

Responsibilities

Coordinate and conduct assigned clinical trials from study start-up through close-out in compliance with regulatory and sponsor requirements.
Maintain comprehensive, accurate, and organized regulatory and subject documentation including informed consent forms, case report forms (CRFs), source documents, and electronic data entries.
Collaborate with Principal Investigators (PIs) to ensure protocol adherence, proper documentation, and timely reporting of adverse events (AEs) and serious adverse events (SAEs).
Screen, recruit, and enroll eligible participants in alignment with inclusion/exclusion criteria. Obtain and document informed consent in accordance with IRB requirements.
Schedule and manage subject visits, study procedures, and assessments per protocol requirements.
Collect and process biological specimens when required by protocol, ensuring proper labeling, documentation, and shipping in compliance with IATA guidelines.
Enter data into electronic data capture (EDC) systems in a timely and accurate manner; resolve data queries and maintain audit-ready documentation.
Ensure investigational product (IP) or device accountability, handling, storage, and reconciliation in compliance with protocol and regulatory requirements.
Serve as the primary liaison between OrthoIllinois and study sponsors, contract research organizations (CROs), and monitors during site qualification, initiation, monitoring, and close-out visits.
Prepare for and participate in internal and external audits/inspections, ensuring timely resolution of findings.
Communicate effectively with study sponsors, vendors, investigators, and healthcare professionals to ensure smooth study execution and issue resolution.
Maintain current certifications, CVs, licenses, training records, and required documents for the study team.
Coordinate Institutional Review Board (IRB) submissions, amendments, safety reports, and continuing reviews.
Assist with developing study-specific materials such as source documents, visit checklists, and patient education tools.
Attend investigator meetings, sponsor training sessions, and departmental meetings as needed.
Stay up to date on clinical research regulations, ICH-GCP guidelines, and industry best practices.
Actively participate in quality assurance and improvement efforts, contributing to a culture of compliance and operational excellence.