Job Description

Under general supervision, coordinates the implementation of research protocols approved for activation at the University of Maryland Medical System. Participates in complex clinical trial; ability; ability to work independently. Acts as a resource to the Research Nurse Coordinators.

Principal Responsibilities and Tasks

The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all job duties performed by personnel so classified.

1. Participates in, supervises and conducts complex clinical research studies. * Screens patients for eligibility to enter research studies. Ensures that diagnostic tests required for entry to a study are ordered and performed. Assists physicians and/or principal investigators in obtaining informed consent. * Conducts patient/family education concerning clinical studies. * Administers investigational drugs as required by treatment protocols. * Follows the clinical course of patients entered on clinical research studies by obtaining results of diagnostic studies, assessing patients for complications, and recording patient data onto study forms. * Independently or in collaboration with the departmental research technician, obtains, processes, and ships clinical samples from patients in accordance to protocol guidelines * Records pertinent patient information on flow sheets and other case report forms and delegates these tasks to data management staff when appropriate.
2. Acts as liaison between the institution and the study sponsor by preparing study reports and communicating with clinical study monitors.
3. Maintains clinical database(s) on patients participating in clinical studies and/or seen by a specific clinical service and oversees data entry by data management staff.
4. Assists clinical investigator with study initiation, conduction, and completion. * Communicates with the Institutional Review Board (IRB) and other departmental review committees. * Confirms appropriateness of drug doses in accordance with protocols. * Acts as a consultant to members of the health care team. * Educates faculty and hospital staff by providing written and oral presentations related to protocol treatment administration and procedures. * Communicates treatment modifications and amendments to faculty and staff. * Prepares study results for presentation and/or publication.
5. Prepares and responds to audits conducted by study sponsors.
6. Acts as a resource for the Research Nurse Coordinators.
7. Represents department at research and protocol initiation meetings.

Qualifications

Education and Experience

1. Current licensure in the State of Maryland as a Registered Nurse is required.
2. Five years of direct patient care experience as an RN is required. Previous experience in the conduction of clinical trials is required. Specialized training in a particular specialty/ area of nursing is required.

Knowledge, Skills and Abilities

1. Demonstrated knowledge of computer applications and databases and of personal computer systems is highly desirable.
2. Highly effective verbal and written communication skills are required.
3. Ability to demonstrate knowledge and skills necessary to provide care appropriate to the patient populations(s) served. Ability to demonstrate knowledge of the principles of growth and development over the life span and ability to assess data reflective of the patient's requirements relative to his or her population-specific and age specific needs.

Patient Safety

Ensures patient safety in the performance of job functions and through participation in hospital, department or unit patient safety initiatives.

1. Takes action to correct observed risks to patient safety.
2. Reports adverse events and near misses to appropriate management authority.
3. Identifies possible risks in processes, procedures, devices and communicates the same to those in charge.

Additional Information

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