Description
Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work?
LOCATION: Lancaster, PA - Suburban Outpatient Pavillion
HOURS: Full Time (40 hours per week). Monday-Friday (8am-4:30pm).
Summary:
The Oncology Research Nurse is responsible for conducting studies involving a wide variety of investigational products and various sponsors. This area of research requires dedicated attention and care to ensure subject safety and well-being. The successful candidate will comply with all policies relating to UPHS, JCAHO, GCP and other regulatory standards; a registered nurse with licensure and in good standing to practice in the Commonwealth of Pennsylvania to provide comprehensive professional nursing care in a multi-disciplinary environment.
Responsibilities:
- Assist with initiating study procedures for new investigator-initiated and industry-sponsored clinical trials. Manage all aspects of Phase I – IV clinical trials. Participate in the conduct of audits by study sponsors, CROs, the FDA, the Eastern Oncology Group, the University of Pennsylvania, and other groups.
- Develop and maintain ongoing communication with the clinical teams including, but not limited to: laboratory, infusion, radiology, Advanced Practitioners, triage, inpatient and pharmacy. Provide in-service and support to infusion, clinic or inpatient staff as appropriate. Provide ongoing service education updates to all investigators that have eligible participants for clinical research trials.
- Care for subjects in all age groups from young adult through geriatrics. Establishes nursing plan of care in collaboration with the PI and study team and in accordance with research guidelines and GCP. Coordinate activities of oncology team in caring for subjects. Provide oversight of administration of medications, chemotherapeutic drugs, biologic response modifiers, and other treatment agents or study interventions, as appropriate.
- Review all clinical and laboratory data and adverse events, reporting in real-time to the Principal Investigator (PI) for assessment and review, and communicate with medical staff regarding protocol-specific management of toxicities and adverse events.
- Handle any questions subjects may have regarding protocol specifics, investigational products, lab results, effects of therapies, medications, and symptom management within level of expertise and referring other questions to the PI or medical team in order to obtain guidance or assistance.
- Collect, review and report timely, valid, accurate study data within the timelines specified by the Clinical Trials Agreement. Coordination will also include: transporting specimens, submission of study documents to all applicable institutional committees for initial approval, continuing reviews and for approval of any amendments.
- Provide coverage and support to other research nurses and coordinators to meet departmental/organizational staffing needs.
- Participate in core study team, disease-site group and ongoing protocol training/compliance meetings. Participate in working groups within the research team that will maximize the efficiency and quality of research performed, including developing SOP’s. Act as a mentor to newly hired nurses.
Minimum Required Qualifications:
- Bachelor's degree in Nursing or healthcare related field
- Current licensure as a Registered Nurse, issued by the PA State Board of Nursing
- Two 2+ years clinical oncology experience
- Working knowledge of medical and research terminology
- Comprehension of Federal Regulations for Human Subjects in Research
- Computer competency including proficiency in Microsoft Outlook, Work, Excel, electronic data capture and electronic health records navigation
- Comprehension and certification in Good Clinical Practices (ICH/GCP) for human research. (obtained in department within the first 30 days of employment)
Preferred Qualifications:
- Five 5+ years of clinical oncology experience
- Experience with research or clinical trials
- Oncology certification or other nursing or research certification, or certification eligible
Live Your Life's Work
We are an Equal Opportunity employer. Candidates are considered for employment without regard to race, ethnicity, color, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, marital status, familial status, genetic information, domestic or sexual violence victim status, citizenship status, military status, status as a protected veteran or any other status protected by applicable law.
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