Clinical Research Nurse

Department

BSD MED - Gastroenterology - Clinical Research Staff

About the Department

The Section of Gastroenterology, Hepatology at The University of Chicago is consistently ranked among the best specialty nationally by U.S News and World Report. With nearly 30 specialists on staff, our program plays a leading role in the understanding of digestive diseases and in developing innovative and successful treatments for patients. Since forming the nation’s first full-time department of gastroenterology in 1927, our physicians have continually improved treatments for digestive tract and related disorders by combining medical research, education, and patient care at the highest level.

Job Summary

The Clinical Research Nurse will participate in the conduct of clinical research trials involving various modalities of treatment for patients in the Irritable Bowel Disease Program in the Section of Gastroenterology in the Department of Medicine. The research trials will include multi-centered cooperative group and intergroup trials at a national level, multi-institutional pharmaceutical trials and single and multi-centered trials (Phase I, Phase II, In-house, Investigator Initiated) designed, implemented and coordinated in the Section.

Responsibilities

• Screens and identifies eligible patients in the surrounding medical community.

• Evaluates potential subject data for clinical studies via screening surveys, telephone call or clinic interview.

• Schedules and coordinates research visits.

• Works closely with the study MD to determine which candidates can enter clinical research studies.

• Obtains informed consent from potential subjects after explanation and review in layman's terms of the informed consent.

• Supervises research assistants in performance of above.

• Educates study subjects about study protocol.

• Maintains frequent contact with the subject as necessary via phone, email or letter.

• Conducts clinical study visits in accordance with protocol.

• Demonstrates proficiency in the following areas: a. Vital signs - interprets findings as well as trends. b. Venipuncture and intravenous line placement, in accordance with Universal Precautions; package and ship specimens appropriately. c. Glucose tolerance tests according to established guidelines d. Any procedure required by the study protocol, demonstrate ability to acquire new skills Administer study medication, which may be in oral, subcutaneous, intramuscular or intravenous form.

• Monitors the subject prior to, during and after study drug administration according to the protocol.

• Elicits and assesses adverse experiences and communicates these to the Investigator.

• Evaluates subject laboratory and physical findings with Investigator/sub-investigators; provides or obtains further information from subjects or healthcare providers as required in order to assist in diagnosis and treatment.

• Keeps the subject's primary physician updated on the subject's status by phone calls, faxes, emails and letters.

• Participates in the conduct of clinical research projects/studies involving various modalities of treatment for patients in the Department of Medicine.

• Participates in established and future research programs in the Section.

• Serves as liaison between P.I., sponsoring agent, regulatory groups, patient, family members, referring MD's/community MD's, pharmacist, statistician and other members of the research team.

• Assists in the development of comprehensive databases and participate in Qi/QA projects.

• Applies logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

• Interprets information from caregivers, nurses, or physicians about patient condition, treatment plans, or appropriate activities.

• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications

Experience:

• Previous nursing experience.

Preferred Competencies

• Fundamental working knowledge of clinical research.

• Knowledge of patient care fundamentals, including aseptic principles and techniques.

• Provide direct patient care in