Clinical Research Coordinator II

LRES Corporation; Maywood (IL); On-site; Full time

Job summary

LRES Corporation is seeking a Clinical Research Coordinator II to manage multiple research protocols and ensure compliance with regulations. Ideal candidates will hold a Bachelor's Degree and have 2-5 years of relevant experience. This full-time position is located at Loyola University Medical Center in Maywood, IL, providing a challenging and rewarding environment in clinical research.

Qualifications

• Bachelor's Degree or equivalent training with 2-5 years of related experience.
• SOCRA CCRP or ACRP certification required within 1 year of hire.
• Should have basic knowledge of clinical research practices.

Responsibilities

• Manage and implement multiple research protocols ensuring regulatory compliance.
• Recruit and enroll subjects, collect and maintain data files.
• Serve as primary contact with study participants and oversee study compliance.

Skills

Ability to follow instructions

Clinical judgment

Use of centrifuge

Medication administration

Education

Bachelor's Degree

SOCRA CCRP or ACRP certification

Tools

Excel

WORD

EPIC (EMR)

Job description

Employment Opportunities Designed to Help Us Collaborate in Creation!

Clinical Research Coordinator II

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Position Details

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 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. He/she participates in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies. The successful candidate will 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. The coordinator will 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.

Responsibilities of the CRC II include all the duties and responsibilities if CRC I, as well as the following:
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 studies from startup through close-out.
• In collaboration with the PI & RN, incorporates 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.
-Stepanenko, Nataliia

Minimum Education and/or Work Experience Bachelors 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, make slides for labs, ECG’s 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 Open Date 05/07/2025 Close Date Position Maximum Salary or Hourly Rate $26.00/hr Position Minimum Salary or Hourly Rate $24,00/hr Special Instructions to Applicants 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. Consistently ranked among the nation’s top universities by U.S. News & World Report, Loyola is a STARS Gold-rated institution that is ranked as one of the country’s most sustainable campuses by The Princeton Review and has earned distinctions from AmeriCorps and the Carnegie Foundation for its longstanding record of service and community engagement. Guided by its Jesuit mission and commitment to caring for the whole person, Loyola educates ethical leaders who think critically, act with purpose, and strive to create a more just and sustainable world.

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. To view our benefits in detail, click here .

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 . Quick Link for Posting https://www.careers.luc.edu/postings/32842

Supplemental Questions

Required fields are indicated with an asterisk (*).

* Do you have a bachelor's degree OR equivalent training acquired via work experience or education?

• Yes
• No

* Do you have 2-5 years of job-related work experience?

• Yes
• No

* Why do you want to work for Loyola University Chicago?

(Open Ended Question)

* How did you hear about this employment opportunity?

• Public Job Posting
• Internal Job Posting
• Agency Referral
• Advertisement/Publication
• Personal Referral
• Website
• Other

* How do your personal values align with Loyola University Chicago's mission and values?

(Open Ended Question)

Applicant Documents

Required Documents

Resume

Cover Letter/Letter of Application

Optional Documents

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