Job Description

University of Utah Job Description

Job Summary

Facilitates the conduct of clinical research. Performs administrative and clinical duties including providing patient care within the scope of nursing practice and in compliance with guidelines set by governing agencies. Actual skills and responsibilities may vary according to the specific research project.

Qualifications

An RN license in the state of Utah; two years nursing experience, preferably in a research or intensive care area; demonstrated organizational, communication and human relation skills; and a current Basic Life Support Health Care Provider card or obtain one within one month of hire required.

Bachelor’s degree in Nursing and an understanding of research procedures is preferred. Experience in a specific area of nursing may also be preferred by the hiring department. Knowledge of FDA regulations and IRB procedures and the ability to function independently would be highly desirable. Experience working with experimental drugs and devices may be important in some research projects.

This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Disclaimer

This job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Essential Functions

1. Conducts weekly clinics to examine participating research patients, provide patient care follow-up, and evaluate their progress within the research project.
2. Assists with the design of research projects by making recommendations on the feasibility of using certain protocols and treatment procedures. Determines patient eligibility for a specific research project.
3. Maintains a liaison with drug and/or equipment companies in order to ensure a continuing exchange of information regarding the impact of the drug and/or medical device and other project details.
4. Performs patient education functions by incoming patients and their families of possible implications that may arise by participating in specific research projects, and training them in the proper use of experimental drugs and/or devices.
5. Evaluates research results to determine the efficacy of certain drugs, devices and/or test procedures. Analyzes patients condition and effectiveness of the particular protocol to determine other intervening factors in accounting for certain results.
6. Provides educational training to other staff members to ensure that all medical personnel treating participating patients are accurately trained in the research protocols.
7. Determines liability and accountability issues of research projects by ensuring that all FDA and IRB requirements are met.
8. Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
9. Performs other patient care duties to include responding to emergency situations, answering questions, and following through with the patient to determine possible side effects of certain drugs and/or devices.
10. Maintains investigational logs and records of drugs administered, medical devices monitored, and procedures followed. Prepares reports for companies and regulatory agencies.
11. Some incumbents in this position may coordinate and initiate all details of the research project including developing research protocols, evaluating and writing research results, obtaining and studying data from participating investigators, supplying study sites with needed materials, and makings site visits.
12. Orders drugs or medical devices from outside companies and maintains records of up-to-date inventory.
13. Maintains an adequate knowledge to operate and care for highly technical equipment.

Problem Solving

This position does not generally have any budget authority, but may directly or indirectly supervise one or two medical or other support staff.

This position works independently in providing basic care to patients according to the guidelines of established research protocols. The incumbent can respond to emergency situations within the parameters of his/her training and accountability, however, critical issues are referred to the attending physician. The specific design of the research study is often discussed with the physician in an exchange format, where the incumbent often gives recommendations. This position does not generally supervise others except in an indirect capacity of instructing attending medical personnel in specific treatment procedures. However, some departments may give a Senior Research Nurse training and hiring responsibility for a few support staff members.

A problem the incumbent may encounter involves monitoring any use of experimental equipment and/or drugs closely, as some patients referred to participate on a research study have no other options for recovery available, and their medical state is highly critical. For this reason, the nurse needs to be aware of the patient’s condition, well informed in the use of equipment, and careful in his/her analysis of appropriate actions to take. Another problem rises due to the strict adherence required by research protocols. The nurse is responsible to organize coverage, when not present, to ensure that proper protocols are followed. The incumbent also needs to arrange adequate resources to handle questions and problems that may arise. A third problem for the incumbent presents itself in the importance to accurately assess the efficacy of a particular drug or treatment when the patient may be suffering from a variety of difficulties. The incumbent needs to ensure that the experimental treatment is enhancing rather than debilitating the patient.

A challenge often exists when there appears to be a disparity between the desires of the drug company or FDA requirements and the needs and desires of the patient. This position may need to determine the most effective action to take in order to satisfy both parties.

Comments

Work Environment and Level of Frequency that may be required:

Nearly Continuously: Office environment.

Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids).

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking, standing, sitting. 

Seldom: Bending, reaching overhead.

The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit.  The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient's status and provide care as described in the department's policies and procedures manual.