The primary responsibility of the oncology research nurse is to coordinate all aspects of care for the patient enrolled in a clinical trial. The research nurse is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations.
-Sound conduct of the clinical trial, including but not limited to, recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol requirements. This includes performing required study procedures as applicable.
-Maintenance of accurate and complete documentation, including but not limited to regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, subjects logs and study-related communication.
-Organizational management of all aspects of the trial including but not limited to timeliness in completing case report forms (CRFs), data entry, reporting adverse drug events, managing caseload and managing study files.
-Communication of all protocol-related issues/problems to the appropriate management staff.
-Educates patients regarding protocol procedures and treatment regimen as needed and appropriate. Disseminates relevant study information to medical and nursing staff as it relates to patient care.
-Supports conduct of clinical trials, including travel to physician offices and all St. Luke’s campuses to explain studies/consent to patients and staff, obtain samples (urine, blood, etc.) as required by protocols, deliver drugs, review charts.
-Responsible for ordering and documentation of investigational and commercially available drugs supplied from the National Cancer Institute and other approved clinical trial sponsors as applicable.
-Professional conduct in the presence of subjects, research staff, sponsors, monitors, etc.
-Provide direction/training to other members of research staff as appropriate. For example, guidance to clinical research associate in completing case report forms.
-Travel to required protocol meetings. For example, attendance at national cooperative group meetings or attendance at sponsor driven investigator meetings.
-Preparation and shipping of laboratory specimens to study (central) laboratories and maintenance of appropriate certifications related to this function (for example, IATA training).
-Maintains confidentiality of all materials handled within the Network/ Entity as well as the proper release of information.
-Complies with Network and departmental policies regarding issues of employee, patient and environmental safety and follows appropriate reporting requirements.
-Demonstrates/models the Network’s Service Excellence Standards of Performance in interactions with all customers (internal and external).
-Demonstrates Performance Improvement in the following areas as appropriate: Clinical Care/Outcomes, Customer/Service Improvement, Operational System/Process, and Safety.
-Demonstrates financial responsibility and accountability through the effective and efficient use of resources in daily procedures, processes and practices.
-Complies with Network and departmental policies regarding attendance and dress code.
-Demonstrates competency in the assessment, range of treatment, knowledge of growth and development and communication appropriate to the age of the patient treated.
Functions as liaison between the St. Luke’s University Health Network and the major study groups/sponsors in order to fulfill standards of care set forth by the protocol. Other related duties as assigned.
PHYSICIAL AND SENSORY REQUIREMENTS:
Requires sitting for up to seven hours per day, 3 hours at a time. Standing for up to 4 hours per day, 3 hours at time. Requires occasional fingering, handling and twisting and turning. Occasionally requires lifting, carrying and pushing and pulling objects weighing up to 20 pounds. Occasionally requires reaching above shoulder level. Must have the ability to hear as it relates to normal conversation, seeing as it relates to general vision.
EDUCATION: Registered professional nurse. BSN preferred.
TRAINING AND EXPERIENCE: Strong oncology background and or research experience highly preferred. Research experience highly preferred. Strong interpersonal skills necessary.
St. Luke's University Health Network is a regional network of hospitals, physicians and other related organizations providing care primarily in Lehigh, Northampton, Monroe, Carbon, Schuylkill, Bucks, Montgomery and Berks counties in Pennsylvania and Warren County in New Jersey.
The Network provides services at more than 150 sites. St. Luke's University Health Network is comprised of six hospital sites.