Loyola University Chicago
Clinical Research Coordinator II
Loyola University Chicago, Maywood, Illinois, United States, 60153
Overview
Position Details Job Title:
CLINICAL RESEARCH COORDINATOR II Position Number:
8150021 Job Category:
University Staff Job Type:
Full-Time FLSA Status:
Non-Exempt Campus:
Maywood-Health Sciences Campus Department Name:
HEMATOLOGY ONCOLOGY Location Code:
HEMATOLOGY - ONCOLOGY (06508A) Is this split and/or fully grant funded?
Yes Duties and Responsibilities
The Clinical Research Coordinator II is responsible for the overall management and implementation of an assigned set of multiple research protocols, assuring efficiency and regulatory compliance. These studies will be conducted at Loyola University Medical Center and satellites. The Coordinator will work as part of a clinical trials research team and report to various Principal Investigators, in coordination with Clinical Research Nurse. Responsibilities include: Assisting in the preparation of initial study documents for IRB submission in compliance with all local, state, and federal regulations; advising the IRB of amendment changes to the protocol and completing annual protocol renewals. Recruiting, screening, assisting in the informed consent process, and enrolling subjects in accordance with good clinical practice (GCP) guidelines. Collecting, recording, and maintaining complete data files using GCP in accordance with HIPAA regulations. Participating in data retrieval, reporting, and preparation of files and Case Report Forms for various studies. Interacting with subjects by scheduling diagnostic and research evaluation visits; performing study-related assessments including collection of blood samples, processing, and shipment. Maintaining drug accountability, adequate study supplies, and equipment. Overseeing subject compliance to the study protocol, obtaining information on medication changes or adverse events, and promptly reporting findings to physicians for documentation in the subject's medical record. Reporting all serious adverse events promptly to investigators, sponsors, and the IRB. Protecting the rights, safety, and well-being of human subjects involved in clinical trials. Additional CRC II responsibilities include all duties of CRC I and: Developing an in-depth understanding of each study protocol to ensure adherence to FDA, GCP, and ICH guidelines. Serving as primary contact with research participants, sponsors, and regulatory agencies; coordinating studies from startup through close-out. Collaborating with the PI and RN to identify potential participants based on inclusion/exclusion criteria; coordinating collection of study specimens and processing. Collecting and managing patient and laboratory data; managing project databases, flow sheets, and study documents/CRFs. Ensuring compliance with study protocols; reviewing and auditing CRFs against source documents; preparing regulatory submissions and ensuring IRB renewals are completed. Assembling study kits, monitoring scheduling of procedures and charges, coordinating documents, and attending monitoring meetings with sponsors as primary contact. Ensuring adherence to study budgets and resolving billing issues with finance/management staff. Interacting with the principal investigator to ensure patient safety and proper study conduct. Maintaining essential documentation and recording of patient and research data per institutional and regulatory requirements. Participating in monitor visits and regulatory audits. Regulatory responsibilities: processing local IRB submissions for new projects, amendments, adverse events, and terminations. Minimum Education and/or Work Experience
Bachelor’s Degree OR equivalent training acquired via work experience or education and 2-5 years of previous job-related experience Qualifications
Ability to follow oral and written instructions and established procedures May require use of centrifuge, making slides for labs, ECGs to be performed and transmitted Medication administration Certificates/Credentials/Licenses
SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire. Computer Skills
Should have basic knowledge in Excel, WORD, EPIC (EMR for the hospital), and Internet-based data submission. 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
None Dates
Open Date:
05/07/2025 Close Date: Salary
Position Maximum Salary or Hourly Rate:
26.00/hour Position Minimum Salary or Hourly Rate:
28.00/hour 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, consult
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 academic excellence, commitment to community engagement, and leadership in sustainability. A Carnegie R1 research institution, Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy. The university emphasizes transformative education and sustainable practices, with numerous accolades and a mission to educate ethical leaders who think critically and act with purpose. Loyola University Chicago strives to be an employer of choice by offering a wide array of affordable, comprehensive, and competitive benefits. For details, view the university benefits. Loyola adheres to applicable civil rights laws and regulations prohibiting discrimination in private higher education. See the University’s Nondiscrimination Policy. Quick Link for Posting
https://www.careers.luc.edu/postings/32842
#J-18808-Ljbffr
Position Details Job Title:
CLINICAL RESEARCH COORDINATOR II Position Number:
8150021 Job Category:
University Staff Job Type:
Full-Time FLSA Status:
Non-Exempt Campus:
Maywood-Health Sciences Campus Department Name:
HEMATOLOGY ONCOLOGY Location Code:
HEMATOLOGY - ONCOLOGY (06508A) Is this split and/or fully grant funded?
Yes Duties and Responsibilities
The Clinical Research Coordinator II is responsible for the overall management and implementation of an assigned set of multiple research protocols, assuring efficiency and regulatory compliance. These studies will be conducted at Loyola University Medical Center and satellites. The Coordinator will work as part of a clinical trials research team and report to various Principal Investigators, in coordination with Clinical Research Nurse. Responsibilities include: Assisting in the preparation of initial study documents for IRB submission in compliance with all local, state, and federal regulations; advising the IRB of amendment changes to the protocol and completing annual protocol renewals. Recruiting, screening, assisting in the informed consent process, and enrolling subjects in accordance with good clinical practice (GCP) guidelines. Collecting, recording, and maintaining complete data files using GCP in accordance with HIPAA regulations. Participating in data retrieval, reporting, and preparation of files and Case Report Forms for various studies. Interacting with subjects by scheduling diagnostic and research evaluation visits; performing study-related assessments including collection of blood samples, processing, and shipment. Maintaining drug accountability, adequate study supplies, and equipment. Overseeing subject compliance to the study protocol, obtaining information on medication changes or adverse events, and promptly reporting findings to physicians for documentation in the subject's medical record. Reporting all serious adverse events promptly to investigators, sponsors, and the IRB. Protecting the rights, safety, and well-being of human subjects involved in clinical trials. Additional CRC II responsibilities include all duties of CRC I and: Developing an in-depth understanding of each study protocol to ensure adherence to FDA, GCP, and ICH guidelines. Serving as primary contact with research participants, sponsors, and regulatory agencies; coordinating studies from startup through close-out. Collaborating with the PI and RN to identify potential participants based on inclusion/exclusion criteria; coordinating collection of study specimens and processing. Collecting and managing patient and laboratory data; managing project databases, flow sheets, and study documents/CRFs. Ensuring compliance with study protocols; reviewing and auditing CRFs against source documents; preparing regulatory submissions and ensuring IRB renewals are completed. Assembling study kits, monitoring scheduling of procedures and charges, coordinating documents, and attending monitoring meetings with sponsors as primary contact. Ensuring adherence to study budgets and resolving billing issues with finance/management staff. Interacting with the principal investigator to ensure patient safety and proper study conduct. Maintaining essential documentation and recording of patient and research data per institutional and regulatory requirements. Participating in monitor visits and regulatory audits. Regulatory responsibilities: processing local IRB submissions for new projects, amendments, adverse events, and terminations. Minimum Education and/or Work Experience
Bachelor’s Degree OR equivalent training acquired via work experience or education and 2-5 years of previous job-related experience Qualifications
Ability to follow oral and written instructions and established procedures May require use of centrifuge, making slides for labs, ECGs to be performed and transmitted Medication administration Certificates/Credentials/Licenses
SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire. Computer Skills
Should have basic knowledge in Excel, WORD, EPIC (EMR for the hospital), and Internet-based data submission. 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
None Dates
Open Date:
05/07/2025 Close Date: Salary
Position Maximum Salary or Hourly Rate:
26.00/hour Position Minimum Salary or Hourly Rate:
28.00/hour 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, consult
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 academic excellence, commitment to community engagement, and leadership in sustainability. A Carnegie R1 research institution, Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy. The university emphasizes transformative education and sustainable practices, with numerous accolades and a mission to educate ethical leaders who think critically and act with purpose. Loyola University Chicago strives to be an employer of choice by offering a wide array of affordable, comprehensive, and competitive benefits. For details, view the university benefits. Loyola adheres to applicable civil rights laws and regulations prohibiting discrimination in private higher education. See the University’s Nondiscrimination Policy. Quick Link for Posting
https://www.careers.luc.edu/postings/32842
#J-18808-Ljbffr