Job Title
CLINICAL RESEARCH COORDINATOR I
Work Modality
Hybrid – 4 In-Person
Is this request for the creation of a new Position (or the modification of an existing Position) to temporarily support the WorkDay ERP?
Job Category
University Staff
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 CRC I 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
Certificates/Credentials/Licenses
N/A
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 www.luc.edu/mission/. For information about the university’s focus on transformative education, they should consult our website at 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 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/34680
