The primary responsibility of the Oncology Research Nurse I 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.
JOB DUTIES AND RESPONSIBILITIES:
1. 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.
2. 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.
3 . 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
4. Communication of all protocol-related issues/problems to the appropriate management staff, and proper communication to the necessary staff in accordance with billing compliance processes.
5. 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.
6. 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.
7. 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.
8. Professional conduct in the presence of subjects, research staff, sponsors, monitors, etc.
9. Provide direction/training to other members of research staff as appropriate. For example, guidance to clinical research associate in completing case report forms.
10. Travel to required protocol meetings. For example, attendance at national cooperative group meetings or attendance at sponsor driven investigator meetings.
11. Preparation and shipping of laboratory specimens to study (central) laboratories and maintenance of appropriate certifications related to this function (for example, IATA training).
12. Maintains confidentiality of all materials handled within the Network/ Entity as well as the proper release of information.
13. Complies with Network and departmental policies regarding issues of employee, patient and environmental safety and follows appropriate reporting requirements.
14. Demonstrates/models the Network’s Service Excellence Standards of Performance in interactions with all customers (internal and external).
15. Demonstrates Performance Improvement in the following areas as appropriate: Clinical Care/Outcomes, Customer/Service Improvement, Operational System/Process, and Safety.
16. Demonstrates financial responsibility and accountability through the effective and efficient use of resources in daily procedures, processes and practices.
17. Complies with Network and departmental policies regarding attendance and dress code.
18. Demonstrates competency in the assessment, range of treatment, knowledge of growth and development and communication appropriate to the age of the patient treated.
19. Other related duties as assigned.
PHYSICIAL AND SENSORY REQUIREMENTS:
Requires sitting for up to seven hours per day, 4 hours at a time. Standing for up to 4 hours per day, 3 hours at time. Requires frequent 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 with current licensure required.
TRAINING AND EXPERIENCE:
Oncology background and research experience preferred.
Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!!
St. Luke's University Health Network is an Equal Opportunity Employer.Skills Required
- Registered professional nurse (RN)
- 2+ years direct oncology clinical trials experience
- In-depth knowledge of protocol requirements and Good Clinical Practice/federal regulations
- Experience with regulatory documentation, consent forms, CRFs, source documentation, and drug dispensing logs
- Experience handling, ordering, and documenting investigational and commercially available drugs
- Maintenance of appropriate certifications related to specimen shipping (for example, IATA training)
- Clinical Research certification (SoCRA, ACRP, or similar)
What We Do
St. Luke's University Health Network is the largest employer and most recognized health system in the greater Lehigh Valley, with a history spanning over 150 years.
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