Clinical Research Coordinator

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

Primary Duties and Responsibilities

Study Coordination and Compliance

• 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.

Study Operations and Data Collection

• 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.

Sponsor & Stakeholder Coordination

• 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.

Regulatory & Administrative Support

• 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.

Continuous Learning & Quality Improvement

• 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.

Competencies:

• Service: We align our actions and decision making with the organization's guiding platform keeping our patients at the center of all we do.

• Change Agent: We support and contribute to positive change in the organization.

• Communication and Interpersonal Relations: We communicate honestly and with compassion to build connections with our patients and each other.

• Effectiveness: We take ownership of work, doing the right thing for our customer and doing it well.

Organizational Culture:

All OrthoIllinois employees focus on service by putting the mission, vision, and value statements into practice and using the guiding principles of Compassion, Respect, Trust, Integrity, Innovation, Education Fiscal Responsibility, Practice Independence, Accountability, and Empowerment to direct their interactions and decision making. Employees promote and model the service standards to create lasting impressions, extraordinary moments, exceptional on-stage experiences, and meaningful and compassionate connections.

Education and Experience Requirements:

• Bachelor's degree relevant field required

• Master's degree in Medical Bio Technology preferred

• Experience in a clinical or research setting preferred

• Effective written and verbal communications

• Knowledge in MS Word/Excel/PowerPoint and Google apps (email, drive, calendar, excel, notepad, etc.)

Education and Experience Requirements:

• Bachelor's degree in a health-related field required (e.g., nursing, life sciences, public health, or clinical research).

• 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).

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

• Familiarity with EDC platforms, eRegulatory systems, and ePRO is a plus.

• GCP certification is preferred.

Environmental/Working Conditions:

Working environment is in an office/clinic setting.

Physical/Mental Demands:

• Sit or stand for long periods of time, walk for periods of time, kneel, crawl, stoop and climb stairs.

• Requires lifting, carrying, or moving heavier objects (i.e. pushing or pulling up to 100 pounds and lifting and carrying up to 50 pounds

• Vision: Posses close, distant, peripheral and color vision and ability to adjust focus

• Hearing: ability to detect high pitch, soft or distant sounds

This description is intended to provide only basic guidelines for meeting job requirements. Responsibilities, knowledge, skills, abilities and working conditions may change as needs evolve.

Equal Opportunity Employer
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