Current UPHS employees must apply HERE
Oncology Research Nurse Coordinator
Job ID: 165816
Category: Clinical Support
Work Type: FT
Location: West Chester, PA, United States
Date Posted: Jan 4, 2023
Work Schedule: Full Time Day Shift
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?
- The Oncology Research Nurse Coordinator is responsible for managing complex oncology studies involving a wide variety of investigational products and various sponsors ensuring subject safety and well-being. Serves as the clinical point person for protocol execution, preparation and oversight of regulatory documentation of study protocols, consent forms, adverse event , and other essential communications and submission to the IRB (local, CIRB). Participates in the development/management of study budgets. Manages and maintains study and data integrity (pre-initiation, active study, follow up, and study closure. Interface with the regulatory authorities, sponsors and cooperative groups.
- The Oncology Research Nurse Coordinator is responsible to ensure that all new patients of the Abramson Cancer Center-Chester County are screened for eligibility for opened clinical studies. Participates in oncology tumor conferences by screening patients that are presented for eligibility in clinical studies and reporting relevant findings at the meeting. Participate in clinic alongside physicians and other clinical staff members to explain the trial schedule of events and assist with coordination of trial assessments and procedures. Accountable for meeting the annual recruitment requirements for ECOG-ACRIN, NRG, NAPBC, and CoC.
Must be able to work independently with minimal supervision. Function as a positive role model, promote multidisciplinary collaboration and identifies and implements research studies. The successful candidate will comply with all policies relating to UPHS, JCAHO, Good Clinical Practice (GCP) and other regulatory standards.
- Care for subjects in all age groups from young adult through geriatrics. Establishes nursing plan of care in collaboration with the Principal Investigator (PI) and study team and in accordance with research guidelines and GCP. Coordinate activities of oncology team in caring for subjects. Administer or provide oversight of administration of medications, chemotherapeutic drugs, biologic response modifiers, cellular immunotherapies and other treatment agents or study interventions, as appropriate.
- Accommodate the diverse needs of study subjects and their families. Provide psychosocial support and make suggestions or referrals to other professional staff (i.e. social worker, chaplain) as needed. Ensure subjects are educated regarding protocol specifics and investigational product. Intercept and respond to subject’s phone calls and emails. Anticipates subject’s concerns and provide appropriate reassurances. Handle any questions subjects may have regarding protocol specifics, investigational products, lab results, effects of therapies, medications, and symptom management within clinical scope and level of expertise and referring other questions to the PI or medical team in order to obtain guidance.
- Demonstrates expertise in subject assessment related to malignancies and related diseases and treatment as evidenced by documentation and observation. Obtains information and interprets it in terms of each subject’s needs. Must be able to prioritize urgent and routine problems including changes in subject’s condition or lab values which require immediate intervention by the PI or medical team. This involves a thorough understanding of disease processes, treatments, side effects, short and long-term complications.
- Independently manage all aspects of complex clinical trials which may include, but is not limited to: creating chemo orders in collaboration with Research Pharmacist and the Beacon team; screening and confirming eligibility; obtaining informed consent; enrollment and registration of study participants; scheduling and ordering of study-related office visits, laboratory testing and radiology exams; ensuring all tests and procedures are billed to the research study or the subject’s insurance according to the billing plan; medication reconciliation and collection of medical history; physical assessments (i.e. vital signs and ECGs); recording assessment findings, education, interventions and plans on the appropriate forms and electronic documents; reviewing subjects’ test results for abnormalities and trends, and collaborating with MD or NP for follow-up; collection and dissemination of subject data; entry of subject data in study databases, participation in initiation, monitoring, and close-out visits with sponsors and CROs; participation in the conduct of audits by study sponsors, CROs, the FDA, Cooperative Study Groups, (NRG, ECOG-ACRIN, SWOG, etc.), the University of Pennsylvania’s CTSRMC, and other groups.
- Reviews the CTSU and ECOG sites and identifies studies that may be of interest to our patients and makes recommendations. Collaborates with Principal Investigators and the Director of Research to assist in the review and selection of oncology research studies.
- Provides regulatory oversight. Participate in the development/maintenance of IRB submissions and regulatory files, including submission of study documents to all applicable institutional committees (e.g., IRB, CTSRMC)for initial approval, continuing reviews and for approval of any amendments.
- Maintains a comprehensive list and brief description of all open-to-enrollment oncology studies. Distributes this list as requested at the Cancer Committee, Breast Health Task Force, and other committees as appropriate.
- Plans and participates in subject recruitment, enrollment, and retention activities.
- Screens and determines potential eligibility of patients and discusses study with attending oncologist for a collaborative approach to the patient. This includes new patients and patients being presented at tumor conference.
- Enrolls eligible patients after obtaining informed consent and coordinates study events according to study protocol.
- Collaborates and communicates with essential members of Pharmacy, Laboratory, Radiology, and Pathology to conduct oncology research studies in a team building manner.
- Provide in-service and support to infusion or inpatient staff as appropriate. Provide ongoing service education updates to all investigators and CCH staff that have eligible participants for clinical research trials as needed. Acts as a resource for the treating physician.
- Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality.
- Provides close supervision of the study patient while undergoing active treatment and in the post treatment phase to adhere to the requirements of the protocol and acts as a resource for the treating physician. Schedule and oversee participant visits and any necessary testing and appointment coverage according to protocol and in accordance with GCP (e.g. within the appropriate window, ensuring all tests and assessments at each visit are performed, maintain detailed documentation of study activities) and transporting and shipment of specimens.
- Monitor subject status and treatment side effects throughout the entire study period in concert with investigators. Review all clinical and laboratory data and adverse events, reporting in real-time to the PI for assessment, review and appropriate follow-up, and communicate with medical staff regarding protocol-specific management of toxicities and adverse events.
- Collect, review and report timely, valid, accurate study data within the timelines specified by the Clinical Trials Agreement and Study Protocol.
- Fulfills all aspects of data management responsibilities including IRB submissions, abstracting, follow-up, tracking of results, communicating with physicians and sponsors, and research participants within the required time frames.
- Fulfills all aspects of study drug management, monitoring, and accounting with accuracy.
- Responds to sponsor queries and requests in a timely basis. Works collaboratively with site monitors and auditors.
- Attends off-site meetings, protocol reviews and training related to specific research projects as able.
- Performs responsibilities with a concentrated focus and attention to details and maintains a high level of accuracy.
- Collaborates with oncology research team to have representation at oncology tumor and breast health task force meetings.
- Prepares for audits collaboratively with the oncology research team and provides assistance to the auditors.
- Maintains required research educational requirements, (i.e. HSP, GCP, Shipping).
- Provide coverage and support to other research nurses and coordinators to meet departmental/organizational staffing needs
- Performs duties in accordance with Penn Medicine and entity values, policies, and procedures
- Other duties as assigned to support the unit, department, entity, and health system organization
- Registered Nurse - PA (Required)
- Current Pennsylvania RN License required.
Education or Equivalent Experience:
- Master of Arts or Science (Preferred)
- Bachelor's Degree in Nursing (Required)
- 3+ years Providing direct care and treatment to oncology patients. Experience as a research nurse conducting oncology cooperative group and/or industry sponsored studies required. Proficient in regulatory component of clinical research. Computer literacy required and proficient in Excel preferred. Excellent written and verbal skills required along with problem resolution skills and attention to details. (Required)
We believe that the best care for our patients starts with the best care for our employees. Our employee benefits programs help our employees get healthy and stay healthy. We offer a comprehensive compensation and benefits program that includes one of the finest prepaid tuition assistance programs in the region. Penn Medicine employees are actively engaged and committed to our mission. Together we will continue to make medical advances that help people live longer, healthier lives.
Live Your Life's Work
We are an Equal Opportunity and Affirmative Action 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.
Current UPHS employees must apply HERE