LRES Corporation
Clinical Research Coordinator II (IITs)
LRES Corporation, Chicago, Illinois, United States, 60290
Employment Opportunities Designed to Help Us Collaborate in Creation!
Clinical Research Coordinator II (IITs) Position Title: CLINICAL RESEARCH COORDINATOR II Job Number: 8150814 Job Category: University Staff Job Type: Full‑Time Campus: Maywood‑Health Sciences Department: RADIATION ONCOLOGY
Coordination Responsibilities
Develops 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 multi‑site studies from startup through close‑out. Facilitate and manage communication between Study sites, and communication with the Coordinating Center.
In collaboration with the Principal Investigator (PI) and Manager, develop Study operations manual, data collection forms, case reports and other source documents for Investigator initiated Studies.
In collaboration with the PI & RN, incorporate clinical judgment and knowledge of protocol 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, and 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 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.
Other duties as assigned.
Minimum Education and/or Work Experience
Bachelor’s Degree OR equivalent training acquired via work experience or education.
2 – 5 years of previous job‑related experience.
SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire.
Qualifications
Ability to follow oral and written instructions and established procedures.
Ability to perform basic filing, office procedures and word processing.
Ability to maintain accuracy and consistency.
Ability to communicate verbally.
Ability to finish tasks in a timely manner.
Ability to maintain confidentiality.
Ability to compose letters and memorandums.
Ability to deal calmly and courteously with people.
Ability to analyze and interpret data.
Ability to function independently and manage own time and work tasks.
Ability to work as an effective Team member.
Ability to organize workflow.
Ability to negotiate, persuade and establish direction.
Ability to maintain office files and follow standard office procedures.
Skilled job requiring high level of adaptability & interpersonal skills.
Ability to interact with internal and external constituents.
Certificates/Credentials/Licenses
CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP) is required.
Computer Skills
Proficiency with Microsoft Word, Groupwise, EPIC, Microsoft Excel, Basic Keyboarding Skills, Adobe Acrobat, Beacon.
Clinical Trials Management System.
Electronic data entry web‑based databases.
Job Information
Supervisory Responsibilities: None
Vehicle Operation: No
Direct Patient Contact: Yes
Physical Demands: None
Working Conditions: None
Open Date: 11/10/2025
Close Date: Position
Maximum Salary or Hourly Rate: $30/hr
Minimum Salary or Hourly Rate: $28/hr
Special Instructions to Applicants As a Jesuit, Catholic institution of higher education, Loyola seeks candidates who will contribute to its mission. Please see our mission at www.luc.edu/mission/ and our transformative education at www.luc.edu/transformativeed.
Equal Employment Opportunity Statement 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.
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Clinical Research Coordinator II (IITs) Position Title: CLINICAL RESEARCH COORDINATOR II Job Number: 8150814 Job Category: University Staff Job Type: Full‑Time Campus: Maywood‑Health Sciences Department: RADIATION ONCOLOGY
Coordination Responsibilities
Develops 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 multi‑site studies from startup through close‑out. Facilitate and manage communication between Study sites, and communication with the Coordinating Center.
In collaboration with the Principal Investigator (PI) and Manager, develop Study operations manual, data collection forms, case reports and other source documents for Investigator initiated Studies.
In collaboration with the PI & RN, incorporate clinical judgment and knowledge of protocol 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, and 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 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.
Other duties as assigned.
Minimum Education and/or Work Experience
Bachelor’s Degree OR equivalent training acquired via work experience or education.
2 – 5 years of previous job‑related experience.
SOCRA CCRP or ACRP certification OR equivalent CRO industry experience with certification obtained within 1 year of hire.
Qualifications
Ability to follow oral and written instructions and established procedures.
Ability to perform basic filing, office procedures and word processing.
Ability to maintain accuracy and consistency.
Ability to communicate verbally.
Ability to finish tasks in a timely manner.
Ability to maintain confidentiality.
Ability to compose letters and memorandums.
Ability to deal calmly and courteously with people.
Ability to analyze and interpret data.
Ability to function independently and manage own time and work tasks.
Ability to work as an effective Team member.
Ability to organize workflow.
Ability to negotiate, persuade and establish direction.
Ability to maintain office files and follow standard office procedures.
Skilled job requiring high level of adaptability & interpersonal skills.
Ability to interact with internal and external constituents.
Certificates/Credentials/Licenses
CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP) is required.
Computer Skills
Proficiency with Microsoft Word, Groupwise, EPIC, Microsoft Excel, Basic Keyboarding Skills, Adobe Acrobat, Beacon.
Clinical Trials Management System.
Electronic data entry web‑based databases.
Job Information
Supervisory Responsibilities: None
Vehicle Operation: No
Direct Patient Contact: Yes
Physical Demands: None
Working Conditions: None
Open Date: 11/10/2025
Close Date: Position
Maximum Salary or Hourly Rate: $30/hr
Minimum Salary or Hourly Rate: $28/hr
Special Instructions to Applicants As a Jesuit, Catholic institution of higher education, Loyola seeks candidates who will contribute to its mission. Please see our mission at www.luc.edu/mission/ and our transformative education at www.luc.edu/transformativeed.
Equal Employment Opportunity Statement 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