Clinical Research Coordinator I - $22.6 - $31.2 An Hour
CLINICAL RESEARCH COORDINATOR IPosition located in the Radiation Oncology Department at Loyola University Chicago. Work modality: Fully In-Person. Employment type: Tempo pieno, Non-Exempt (FLSA).ResponsibilitiesDevelop an in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines.Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close‐out.In collaboration with the Principal Investigator and Registered Nurse, incorporate clinical judgment and protocol knowledge to identify potential study participants according to inclusion and exclusion criteria.Coordinate collection of study specimens and processing.Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study‐related documents, and complete study documents and case report forms.Ensure compliance with research protocols, review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed.Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as the primary contact.Ensure adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.Participate in monitor visits and regulatory audits.Perform other duties as assigned.Regulatory ResponsibilitiesEstablish and maintain the research project's regulatory files.Ongoing communication with the local IRB, federal organizations, affiliate institutions,
and pharmaceutical study sponsors.Process local IRB submissions to include new research projects, amendments, adverse events, and study terminations.Participate in cooperative group audits, FDA, sponsor GCP quality audits, Loyola internal audits, and department audits.Perform related duties as assigned.Data Management ResponsibilitiesCollects, records, and maintains accurate data reporting adhering to protocol data collection protocol and federal guidelines. Clarifies data queries.Specimen handling and shipping responsibilities: coordinate with the Clinical Research RN to organize procurement of research samples and then prepares, packages and ships research samples. Manage research sample supplies.Participate in cooperative group audits, FDA, sponsor GCP quality audits, Loyola internal audits and department audits.Perform related duties as assigned.Minimum Education and/or Work ExperienceBachelor's Degree OR equivalent training acquired via work experience or education.Preferred QualificationsExperience with oncology population.Project management skills.Excellent written and verbal communication skills.Experience working in clinical trials.Certificates/Credentials/LicensesCCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP).Computer SkillsProficiency with Microsoft Word, GroupWise, EPIC, Microsoft Excel, basic keyboarding skills, Adobe Acrobat, Beacon.Clinical Trials Management System.Electronic data entry web‐based databases.Supervisory Responsibilities: None.No required operation of university‐owned vehicles.This position requires direct patient contact: Yes.Physical Demands: None.Working Conditions: None.Open Date: 04/27/2026.Close Date: N/A.Position Minimum Salary or Hourly Rate: $22.60/hour.Position Maximum Salary or Hourly Rate: $31.25/hour.Loyola University Chicago adheres to all applicable federal, state, and/or local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. Please see the University's Nondiscrimination Policy.#J-18808-Ljbffr
and pharmaceutical study sponsors.Process local IRB submissions to include new research projects, amendments, adverse events, and study terminations.Participate in cooperative group audits, FDA, sponsor GCP quality audits, Loyola internal audits, and department audits.Perform related duties as assigned.Data Management ResponsibilitiesCollects, records, and maintains accurate data reporting adhering to protocol data collection protocol and federal guidelines. Clarifies data queries.Specimen handling and shipping responsibilities: coordinate with the Clinical Research RN to organize procurement of research samples and then prepares, packages and ships research samples. Manage research sample supplies.Participate in cooperative group audits, FDA, sponsor GCP quality audits, Loyola internal audits and department audits.Perform related duties as assigned.Minimum Education and/or Work ExperienceBachelor's Degree OR equivalent training acquired via work experience or education.Preferred QualificationsExperience with oncology population.Project management skills.Excellent written and verbal communication skills.Experience working in clinical trials.Certificates/Credentials/LicensesCCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP).Computer SkillsProficiency with Microsoft Word, GroupWise, EPIC, Microsoft Excel, basic keyboarding skills, Adobe Acrobat, Beacon.Clinical Trials Management System.Electronic data entry web‐based databases.Supervisory Responsibilities: None.No required operation of university‐owned vehicles.This position requires direct patient contact: Yes.Physical Demands: None.Working Conditions: None.Open Date: 04/27/2026.Close Date: N/A.Position Minimum Salary or Hourly Rate: $22.60/hour.Position Maximum Salary or Hourly Rate: $31.25/hour.Loyola University Chicago adheres to all applicable federal, state, and/or local civil rights laws and regulations prohibiting discrimination in private institutions of higher education. Please see the University's Nondiscrimination Policy.#J-18808-Ljbffr