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Health Systems Clinical Research

JOB DESCRIPTION

Job Title:
Clinical Research Coordinator I

Department:

Clinical Research Operations

Location:

On-site (Insight Hospital & Medical Center – Chicago)

Schedule:

Full-time, Monday through Friday (8AM–5PM)

Reports To:

Director of Clinical Trials and Clinical Research Coordinator III – Team Lead

Position Summary

The Clinical Research Coordinator I (CRC I) is responsible for supporting the conduct of clinical trials under direct supervision from senior coordinators and the CRC III – Team Lead or the Director of Clinical Trials. The CRC I supports the coordination of study activities across all phases, including participant recruitment, screening, enrollment, and data collection. This role builds foundational skills in GCP, regulatory processes, and clinical trial operations while contributing to the overall success of the site's research portfolio. The CRC I collaborates with the Patient Recruitment department, regulatory resources, and the broader clinical research team to ensure protocol adherence, participant safety, and data integrity.

Core Competencies

- Foundational knowledge of clinical trial operations, Good Clinical Practice (GCP), FDA regulations, and IRB processes
- Strong organizational skills with attention to detail and the ability to manage multiple priorities under supervision
- Effective communication and interpersonal skills with study participants, team members, and external stakeholders
- Commitment to participant safety, data integrity, and regulatory compliance
- Eagerness to learn, adapt, and grow within a fast-paced clinical research environment
- Proficiency in electronic health record (EHR) systems; exposure to electronic data capture (EDC) and clinical trial management systems (CTMS) preferred

Key Responsibilities

Study Coordination

- Coordinate assigned clinical trial activities under the direction of the CRC III – Team Lead/Site Director/Site Manager and Principal Investigator
- Coordinate site preparation, study startup, participant screening, enrollment, and follow-up visits
- Ensure protocol adherence, timely data entry, and accurate source documentation for assigned studies
- Prepare for and support monitoring visits, audits, and sponsor interactions

Participant Interaction and Recruitment

- Serve as a point of contact for study participants, providing education about the study and addressing questions
- Obtain and document informed consent in compliance with ICH-GCP and IRB requirements
- Conduct prescreening activities and coordinate with the Patient Recruitment department to support enrollment goals
- Participate in community engagement and outreach activities as directed

Data Collection and Management

- Collect, record, and maintain accurate clinical trial data, ensuring integrity and confidentiality of participant information
- Enter data into EDC systems accurately and within sponsor-required timelines
- Manage query resolution and data clarification as directed by the CRC III – Team Lead or sponsor monitors

Regulatory and Quality Support

- Support preparation and submission of IRB documents, amendments, and safety reports
- Support the maintenance of essential regulatory files and study documentation
- Participate in internal quality assurance activities and assist with CAPA implementation as directed
- Maintain compliance with GCP, institutional policies, and applicable regulatory requirements

Minimum Education and Experience

- Bachelor's degree in life sciences, nursing, healthcare, or a related field preferred; associate's degree with relevant clinical experience considered
- Zero to one year of experience in a clinical, research, or healthcare setting
- Clinical research certification (CCRC, CCRP) eligible; certification expected within 18 months of hire

Qualifications

- Strong understanding of or willingness to learn clinical trial processes and the regulatory environment
- Minimum 1 year experience supporting clinical research study coordination at the site level
- Excellent organizational skills and attention to detail, with the ability to manage multiple priorities and deadlines
- Strong interpersonal and communication skills, with the ability to build rapport with participants and collaborate effectively with team members
- Proficiency in electronic health record (EHR) systems; familiarity with EDC and CTMS platforms preferred
- Phlebotomy skills preferred
- Ability to work both independently and collaboratively in a fast-paced environment
- Professional references may be required