Loyola University Chicago
CLINICAL RESEARCH COORDINATOR II
Loyola University Chicago, Chicago, Illinois, United States, 60290
Overview
Position Number 8150021 | Job Category: University Staff | Job Type: Full-Time | FLSA Status: Non-Exempt | Campus: Maywood-Health Sciences Campus | Department: 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 the Loyola University Medical Center and satellites. He/she will work as part of a clinical trials research team and report to various Principal Investigators conducting clinical research 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; advise the IRB of amendment changes to the protocol and complete annual protocol renewals recruit, screen, assist in the informed consent process and enroll subjects in accordance with good clinical practice guidelines collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations participate in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies interact with subjects by scheduling diagnostic and research evaluation visits, perform study related assessments including collection of blood samples, processing and shipment maintain drug accountability, adequate study supplies and equipment oversee subject compliance to the study protocol, obtain information from the study subject regarding any changes in their medications or adverse events and promptly report the findings to physicians for documentation in the subject’s medical record report all serious adverse events promptly to investigators, sponsors and the IRB protect the rights, safety and well-being of human subjects involved in the clinical trials Additional duties include those of CRC I and: Coordination responsibilities
Develops in-depth understanding of each study protocol to ensure adherence to FDA, GCP, and ICH Guidelines Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out Collaborate with the PI and RN 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/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 IRB 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 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 Regulatory Responsibilities
Processes local IRB submissions to include new research projects, amendments, adverse events and study 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, prepare 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 Direct animal or patient contact
No Physical Demands
Repetitive motions Working Conditions
None Open Date
05/07/2025 Close Date
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/ and www.luc.edu/transformativeed. About Loyola University Chicago
Founded in 1870, Loyola University Chicago is a Jesuit, Catholic university with a strong focus on research, community engagement, and sustainability. Loyola operates multiple campuses and institutes and is recognized for its academic excellence. Loyola adheres to civil rights laws and regulations prohibiting discrimination. See the University’s Nondiscrimination Policy. Quick Link for Posting: https://www.careers.luc.edu/postings/32842 Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology | Industries: Higher Education Referrals increase your chances of interviewing at Loyola University Chicago. Get notified about new Clinical Research Coordinator jobs in Chicago, IL.
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Position Number 8150021 | Job Category: University Staff | Job Type: Full-Time | FLSA Status: Non-Exempt | Campus: Maywood-Health Sciences Campus | Department: 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 the Loyola University Medical Center and satellites. He/she will work as part of a clinical trials research team and report to various Principal Investigators conducting clinical research 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; advise the IRB of amendment changes to the protocol and complete annual protocol renewals recruit, screen, assist in the informed consent process and enroll subjects in accordance with good clinical practice guidelines collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations participate in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies interact with subjects by scheduling diagnostic and research evaluation visits, perform study related assessments including collection of blood samples, processing and shipment maintain drug accountability, adequate study supplies and equipment oversee subject compliance to the study protocol, obtain information from the study subject regarding any changes in their medications or adverse events and promptly report the findings to physicians for documentation in the subject’s medical record report all serious adverse events promptly to investigators, sponsors and the IRB protect the rights, safety and well-being of human subjects involved in the clinical trials Additional duties include those of CRC I and: Coordination responsibilities
Develops in-depth understanding of each study protocol to ensure adherence to FDA, GCP, and ICH Guidelines Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out Collaborate with the PI and RN 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/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 IRB 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 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 Regulatory Responsibilities
Processes local IRB submissions to include new research projects, amendments, adverse events and study 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, prepare 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 Direct animal or patient contact
No Physical Demands
Repetitive motions Working Conditions
None Open Date
05/07/2025 Close Date
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/ and www.luc.edu/transformativeed. About Loyola University Chicago
Founded in 1870, Loyola University Chicago is a Jesuit, Catholic university with a strong focus on research, community engagement, and sustainability. Loyola operates multiple campuses and institutes and is recognized for its academic excellence. Loyola adheres to civil rights laws and regulations prohibiting discrimination. See the University’s Nondiscrimination Policy. Quick Link for Posting: https://www.careers.luc.edu/postings/32842 Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology | Industries: Higher Education Referrals increase your chances of interviewing at Loyola University Chicago. Get notified about new Clinical Research Coordinator jobs in Chicago, IL.
#J-18808-Ljbffr