CLINICAL RESEARCH COORDINATOR II

Join to apply for the CLINICAL RESEARCH COORDINATOR II role at Loyola University Chicago Get AI-powered advice on this job and more exclusive features. Position Number 8150661 Job Category University Staff Job Type Full-Time FLSA Status Non-Exempt Campus Maywood-Health Sciences Campus Department Name RADIATION ONCOLOGY Location Code RADIATION ONCOLOGY (06720A) Is this split and/or fully grant funded? Yes Duties and Responsibilities Develop 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. 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/case report forms. Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Participate in monitor visits and regulatory audits. Regulatory Responsibilities Establish and maintain 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. Prepare regulatory submissions and ensure institutional Review Board renewals are completed. Data Management Responsibilities Collect, record, and maintain accurate data reporting adhering to protocol data collection protocol and federal guidelines. Clarify Data Queries. Specimen handling and shipping responsibilities: coordinate with the Clinical Research RN to organize procurement of research samples, then prepare, package, and ship 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. Coordination Responsibilities In collaboration with the PI & RN, incorporate clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria. Ensure compliance with research protocols, review and audit case report forms for completion and accuracy with source documents. 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. Performs other duties as assigned. Minimum Education and/or Work Experience Bachelor’s Degree or equivalent training acquired via work experience or education. Less than one year of previous job‑related experience. Qualifications Experience with oncology population preferred. Project management skills. Excellent written and verbal communication skills. Experience working in clinical trials highly desirable. Bachelor’s Degree or equivalent training acquired via work experience or education. Less than one year of previous job‑related experience. Certificates, Credentials, Licenses SOCRA CCRP or ACRP certification or equivalent CRO industry experience with certification obtained within 1 year of hire. Computer Skills Computer literacy: word processing, Excel, internet, databases, electronic data capture. Supervisory Responsibilities No Required operation of university owned vehicles No Does this position require direct animal or patient contact? No Physical Demands Repetitive Motions Working Conditions Irregular Hours Open Date Close Date Position Maximum Salary or Hourly Rate $31.25/hr Position Minimum Salary or Hourly Rate $22.60/hr Special Instructions to Applicants As a Jesuit, Catholic institution of higher education, we seek candidates who will contribute to our strategic plan to deliver a Transformative Education in the Jesuit tradition. To learn more about Loyola University Chicago’s mission, candidates should consult our website at www.luc.edu/mission/. For information about the university’s focus on transformative education, they should consult our website at www.luc.edu/transformativeed. About Loyola University Chicago Founded in 1870, Loyola University Chicago is one of the nation’s largest Jesuit, Catholic universities, recognized for its academic excellence, commitment to community engagement, and leadership in sustainability. A Carnegie R1 research institution, Loyola leverages its status as one of an elite group of universities with the highest level of research activity to advance knowledge that serves communities and creates global impact. With 15 schools, colleges, and institutes —including Business, Law, Medicine, Nursing, and Health Sciences—Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy, that provide students a transformative, globally connected learning experience. Loyola University Chicago strives to be an employer of choice by offering its staff and faculty a wide array of affordable, comprehensive, and competitive benefits. Loyola 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