Clinical Research Coordinator I (CRC-1)

INSIGHT Surgical Hospital•Chicago, IL

10h•Onsite

About The Position

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.

Requirements

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
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
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
Ability to work both independently and collaboratively in a fast-paced environment

Nice To Haves

Exposure to electronic data capture (EDC) and clinical trial management systems (CTMS) preferred
Familiarity with EDC and CTMS platforms preferred
Phlebotomy skills preferred

Responsibilities

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
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
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
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