Clinical Research Coordinator I (CRC-1)

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