Research Nurse; Oncology

Research Nurse (Oncology)

The Johns Hopkins University

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. This position reports to the Research Nurse Manager and is responsible for the coordination and implementation of assigned clinical trials within the research program.

• Anticipate research requirements for designated patient populations.
• Review and assess new protocols for clarity, thoroughness, logistical feasibility, and maintenance of subject safety under guidance.
• List and clarify concerns and questions about new protocols with PI and sponsor under guidance.
• Review prospective reimbursement analysis (PRA) as appropriate.

• Review and assess new protocols for clarity, thoroughness, logistical feasibility, maintenance of subject safety, and discuss concerns with PI and sponsor under guidance.
• Review prospective reimbursement analysis (PRA) as appropriate.

• Review consent forms prior to submission to the IRB.
• Prepare other forms required for study initiation (pre‑printed orders, eligibility checklists, etc.) under guidance.
• Determine that IRB approval has been received prior to initiation of research activity.
• Participate in study initiation meetings.
• Prepare space for study‑related equipment and supplies.

• Ensure initial and ongoing eligibility of all subjects for assigned research studies.
• Screen potential research subjects for participation in clinical trials (including review of medical history, concomitant meds, pathology, and other relevant documents).
• Evaluate ongoing eligibility of research subjects’ participation; collaborate with Principal Investigator to obtain exemptions as appropriate.
• Abstract data from a variety of sources to complete pre‑study work‑up.
• Demonstrate and participate in the informed consent process.
• Document obtaining of informed consent in medical record as appropriate.
• Register research subjects per sponsor guidelines.
• Monitor protocol enrollment goals in conjunction with PI.
• Demonstrate knowledge of protocol endpoint definitions.
• Collaborate with healthcare team to evaluate potential subjects for research participation.

• Ensure collection of pertinent data from internal and external sources and monitor compliance with requirements of assigned clinical trials.
• Obtain and ensure proper distribution of required pharmacokinetic and tissue samples.
• Schedule, perform, and/or monitor procedures and tests per protocol requirements.
• Ensure correct documentation of clinical study in medical record and appropriate protocol documents.
• Schedule visits, tests, and procedures for patients entered in clinical trials to ensure results are available in a timely manner.
• Ensure all required signatures are obtained on informed consent documents as appropriate.
• Ensure validity of informed consent documents as appropriate.
• Maintain CRMS database for enrollment.
• Review protocol amendments as required.
• Develop procedure and collection forms for pharmacokinetic sampling.
• Obtain required data through chart review, telephone communication, subject interview, and assessment under guidance and when dictated by the research protocol.
• Coordinate with data managers to ensure delivery of trial data for inclusion into study files.
• Order required medical equipment and supplies with assistance as needed.
• Maintain working knowledge of institutional information systems for correctly scheduling clinical tests and procedures and extracting data.
• Organize own time and set priorities for research‑related functions under guidance.
• Prioritize workload and manage multiple projects effectively under guidance.
• Maintain working knowledge of department‑specific computer software including word processing, e‑mail, and internet functions.
• Be aware of and knowledgeable about departmental Standard Operating Procedures.

• Evaluate outcomes of assigned clinical trials.
• Recognize and document adverse events per protocol and ensure reporting to appropriate study and regulatory personnel; initiate adverse event reports and ensure proper and timely distribution to sponsor…