Clinical Research Nurse

Job description

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Position Number:


Job Category:

University Staff

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Maywood-Health Sciences Campus

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Is this split and/or fully grant funded? :


Duties and Responsibilities:

- Responsible for planning and implementation of a clinical research trial to include but not limited to: coordination with all members/departments/external institutions of the study team, oversight of IRB, regulatory and/or FDA submissions, budget preparation participation, and study management tool development.
- Provides education and training to other health care professionals related to patient participation in a clinical trial.
- Tracks research eligible patients, screens for eligibility, completes informed consent process all the while coordinating the process to insure protocol compliance and provides information support to research team and participants.
- Procures eligibility data and materials, interface with sponsors and investigators as appropriate in determining eligibility.
- Schedules research participant appointments, obtains health history, and administers psychological instruments.
- Oversees study lab specimen collection, processing and shipping, and long term data collection. Acquires necessary certifications to handle shipping of hazardous materials.
- Attends study related meetings/audits.
- Responsible for confidentiality and proper maintenance/storage of all study materials and related documents.
- Prepares and participates in FDA, Sponsor GCP quality audits, Loyola internal audits and department audits.
- Participates in program research planning to include as appropriate, protocol development, data reporting and grant reporting.
- Participates in departmental process improvement activities and national committees as appropriate.
- Collaborates with the PI in case management of research participants; assuring patient safety and compliance with the protocol and regulatory requirements and research patient billing compliance. Communicates with the appropriate clinical staff in coordination of patient care.
- Data management; collecting, data entry of accurate data. Monitor and train clinical protocol coordinators in accurate and timely data collection. Create and maintain source documents for remote monitoring of patient data.
- Collaborates with faculty members to facilitate clinical and translational research with our labs, biospecimen bank repository and biostatistics department.
- Provides oversight and guidance to clinical protocol coordinators regarding several research protocols, IRB submissions and regulatory management.
- Perform related duties as required.

Minimum Education and/or Work Experience:

Minimum Education: Required: Bachelors Degree OR equivalent training acquired via work experience or education Preferred: Bachelors Degree Specify Degree(s): Nursing Minimum Experience: Required: 1-2 years of previous job-related experience Preferred: 3-5 years of previous job-related experience


Under the guidance of the Principal Investigators (PI), the clinical research nurse is responsible for assuring that the integrity and quality of the clinical research trials are maintained and that the trials are conducted in accordance with good clinical practice guidelines, federal and sponsor regulations and Loyola University policy and procedures. This includes, but is not limited to, the investigation of new clinical trial protocols; participation in the development of new funding opportunities; participation in budget preparation regarding specific studies; interaction with multiple sponsor representatives; case management of protocol patients; recruitment and enrollment of human subjects; preparation of adverse event experience reports and audits; construction and monitoring of case report forms (CRFs); maintenance of drug records; report generation; education of other health care professionals, patients, or family; protocol development; provision of direct patient care for research patients as appropriate.

Incumbent must have strong interpersonal and analytical skills, possess a very high attention to detail, and be skilled in organizing resources and establishing priorities. General administrative policies exist, but employee is required to use expertise and judgment to meet objectives. Responsible for consistently demonstrating our MAGIS values of Care, Concern, Respect and Cooperation through teamwork and effective communication in an effort to prevent and solve problems and to achieve quality outcomes, patient safety, customer satisfaction and a safe environment. Loyola is committed to the continuous improvement of the services it provides to its patients and their families.

Work consists of various duties involving different processes and methods. Factors to be considered differ with each assignment, and elements of the work must be identified and analyzed to determine appropriate action.

Patient Population Specific Competencies:
- Demonstrates skills and knowledge necessary to provide appropriate care to specific patient populations served by the specific unit to which the incumbent is assigned.
- Must be able to assess data reflective of the patient’s status and interpret appropriate information needed to identify each patient’s requirement relative to population specific needs.

Reasoning Ability:
- 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 deal with stressful situations.
- 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 lead work teams.
- Ability to organize workflow.
- Ability to plan, coordinate and develop multiple projects.
- Ability to compile complex reports and develop presentations.
- Ability to negotiate, persuade and establish direction.
- Ability to interact with internal and external constituents.
-Willingness to work irregular hours on occasion


Required: Current Registered Nurse License State of Illinois
Preferred: CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP)
Specialty certification in clinical or functional area of nursing granted by a national nursing organization.
IATA (International Air Transport Association)

Computer Skills:

Required: Basic Keyboarding Skills
Preferred: EPIC, Microsoft Outlook, Excel and Word

Supervisory Responsibilities:


Required operation of university owned vehicles:


Physical Demands:


Working Conditions:

Irregular Hours

Open Date:


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Job No:
Posted: 10/28/2020
Application Due: 12/27/2020
Work Type: