Clinical Research Coordinator I

Clinical Research Coordinator I

Job Title - CLINICAL RESEARCH COORDINATOR I

Position Number - 8151017

Work Modality - Hybrid 4 In-Person

Job Category - University Staff

Job Type - Full-Time

FLSA Status - Non-Exempt

Campus - Maywood-Health Sciences Campus

Department Name - CBCC Research

Location Code - HEMATOLOGY - ONCOLOGY (06508A)

Is this split and/or fully grant funded? - Yes

Duties and Responsibilities - Job Summary: Under the guidance of the principal investigator and in conjunction with the Clinical Research Nurse, the CRCI is responsible for assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with good clinical practice guidelines, federal and sponsor regulations and Loyola University Policy and procedures. The Clinical Research Coordinator I 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.

Duties and 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.
• 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.
• Data Management Responsibilities: Collects, records and maintains accurate data reporting adhering to protocol data collection protocol and federal guidelines. Clarifies Data Queries.
• Specimen Handling and Shipping Responsibilities: Coordinates with the Clinical Research RN to organize procurement of research samples and then prepares, packages and ships research samples. Manages research sample supplies.
• Participates in Cooperative Group Audits, FDA, Sponsor GCP quality audits, Loyola internal audits and department audits.
• Performs related duties as assigned

Minimum Education and/or Work Experience - Required Education: Bachelors Degree OR equivalent training acquired via work experience or education Required Experience: Less than one year of previous job-related experience

Qualifications - Ability to analyze and interpret data Ability to communicate verbally Ability to compose letters and memorandums Ability to deal calmly and courteously with people Ability to finish tasks in a timely manner Ability to follow oral and written instructions and established procedures Ability to function independently and manage own time and work tasks Ability to maintain accuracy and consistency Ability to maintain confidentiality Ability to maintain office files and follow standard office procedures Ability to negotiate, persuade and establish direction Ability to organize workflow Ability to perform basic filing, office procedures and word processing Ability to work as an effective team member Knowledge of medical terminology

Computer Skills - Proficient in Microsoft Office suite. REDcap proficiency preferred

Supervisory Responsibilities - No

Required operation of university owned vehicles - No

Does this position require direct animal or patient contact? - Yes

Physical Demands - Repetitive Motions

Working Conditions - Irregular Hours

Position Maximum Salary or Hourly Rate - $28.00 /hr

Position Minimum Salary or Hourly Rate - $24.00 /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 For information about the university's focus on transformative education, they should consult our website at

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 institutesincluding Business, Law, Medicine, Nursing, and Health SciencesLoyola 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