Clinical Research Coordinator

Location: Hinsdale

Job Title:

Clinical Research Coordinator

Job Description

The Clinical Research Coordinator I supports and implements clinical research studies under the direction of the Principal Investigator in accordance with Good Clinical Practice. This role ensures that all research activities uphold the highest standards of regulatory compliance and data integrity while promoting a safe, respectful, and productive environment for study participants. The coordinator also oversees the work of research staff assigned to the study and contributes to the overall quality and efficiency of the research program.

Responsibilities

+ Maintain complete and accurate site regulatory files for all assigned clinical studies.

+ Work directly with Institutional Review Boards (IRBs), including preparing and submitting initial applications, modifications, continuing reviews, and other required documentation.

+ Prescreen, recruit, and screen patients for participation in clinical studies, ensuring eligibility criteria are accurately assessed.

+ Execute the informed consent process in accordance with ICH and GCP guidelines, ensuring that participants fully understand the study and their rights.

+ Create source documents and record study visits in source data according to ALCOA-CCC principles, ensuring accurate, legible, contemporaneous, original, and attributable data.

+ Perform phlebotomy, process blood and urine specimens, and prepare and ship samples according to study protocol and laboratory manuals.

+ Enter source data into electronic data capture (EDC) systems such as Medidata RAVE and respond to data queries in a timely and accurate manner.

+ Perform vital signs, ECGs, and other protocol-required clinical assessments during study visits.

+ Record adverse events and serious adverse events in accordance with sponsor guidance, maintaining timely follow-up to document resolution and outcomes.

+ Monitor, dispense, and collect investigational product while maintaining detailed accountability and temperature logs, and promptly report any temperature excursions.

+ Work within interactive response technology (IRT) systems to manage investigational product and subject randomization as required.

+ Schedule, prepare for, and conduct study visits with sponsors and contract research organizations, including site selection visits (SSV), site initiation visits (SIV), interim monitoring visits (IMVs), and close-out visits (COV).

+ Support the integrity of the research program by adhering to CFR, GCP, and internal policies, and by fostering a safe and productive environment for research subjects.

+ Collaborate with the Principal Investigator and research team to resolve study-related issues and maintain high-quality study conduct.

Essential Skills

+ Bachelors degree in science, psychology, or a related field, or an additional four years of relevant research experience in lieu of a degree.

+ Thorough knowledge of Code of Federal Regulations (CFR) and Good Clinical Practice (GCP) principles.

+ Minimum of 1 year of experience as a Clinical Research Coordinator on Phase IIII pharmaceutical clinical trials.

+ Hands-on phlebotomy skills and ability to perform blood draws as required by study protocols.

+ Proficiency with Microsoft Office Suite, specifically Excel, for data tracking and reporting.

+ Experience working with IRBs, including submissions, modifications, and continuing reviews.

+ Ability to execute informed consent processes in accordance with ICH and GCP guidelines.

+ Competence in entering and managing data in electronic data capture systems such as Medidata RAVE.

+ Ability to perform vitals, ECGs, and other protocol-mandated clinical assessments.

+ Strong understanding of regulatory and clinical research processes, including documentation and reporting of adverse events.

+ Ability to oversee and coordinate the work of research staff assigned to studies.

+ Effective communication and organizational skills to manage multiple studies and deadlines.

Additional

Skills & Qualifications

+ GCP certification is preferred.

+ IATA certification is preferred for handling and shipping biological samples.

+ Experience or interest in nephrology clinical research is beneficial.

+ Familiarity with ICH guidelines and broader clinical research regulatory frameworks.

+ Ability to travel between clinical sites as needed.

+ Strong attention to detail and commitment to maintaining data integrity and regulatory compliance.

Work Environment

This role is primarily based at a clinical research site in Hinsdale,…