Research Nurse (Oncology)

About the role

Reporting to the Research Nurse Manager, the Research Nurse coordinates and implements assigned clinical trials within the research program.

Responsibilities

• Project Management: Anticipates research requirements for designated patient populations; reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintenance of subject safety; lists & clarifies concerns and questions about new protocols with PI and sponsor; reviews prospective reimbursement analysis (PRA) as appropriate.
• Pre‑initiation: Reviews consent forms prior to IRB submission; prepares other forms required for study initiation; confirms IRB approval before initiation; participates in study initiation meetings; prepares space for study‑related equipment & supplies.
• Recruitment & enrollment: Ensures initial & ongoing eligibility of subjects; screens potential subjects (medical history, concomitant meds, pathology, etc.); evaluates ongoing eligibility and collaborates with PI for exemptions; abstracts data for pre‑study work‑up; demonstrates and participates in informed consent process; documents informed consent in medical record; registers subjects per sponsor guidelines; monitors protocol enrollment goals with PI; evaluates potential subjects with healthcare team.
• Data collection/Document maintenance: Ensures collection of pertinent data from internal & external sources; monitors compliance; obtains & distributes required pharmacokinetic & tissue samples; schedules, performs, and/or monitors procedures & tests per protocol; ensures correct documentation in medical record and protocol documents; schedules visits, tests & procedures for timely results; ensures required signatures on informed consent documents; maintains validity of consent documents; maintains CRMS database for enrollment; reviews protocol amendments; develops procedure and collection forms for pharmacokinetic sampling; obtains required data via chart review, telephone, subject interview & assessment; coordinates with data managers for trial data delivery; maintains working knowledge of institutional information systems for scheduling tests & extracting data; organizes own time & sets priorities; prioritizes workload & manages multiple projects.
• Quality Assurance: Evaluates outcomes of assigned clinical trials; recognizes and documents adverse events per protocol & ensures reporting to appropriate study & regulatory personnel; initiates adverse event reports and ensures proper distribution to sponsor and IRB; grades identified toxicities per NCI or protocol‑specific criteria; attends medical staff meetings to review study progress; collaborates with research team to prepare for and respond to study audits.
• Communication: Assists in completion of annual periodic review of data for IRB, sponsors, & cooperative groups; meets regularly with research team to review protocol progress & data collection; attends and participates in research nurse group meetings; completes required documentation for accreditation & annual reviews; attains proficiency in Web‑based communication.
• Education: Ensures patient and staff education needs are met for assigned protocols; ensures development & availability of appropriate patient education materials; determines effectiveness of patient/family education & modifies plan as needed.
• Staff Education: Identifies staff learning needs based on protocol requirements; ensures development & availability of staff education materials; provides staff education (in‑services) related to assigned trials; attends and participates in in‑service and external trainings, workshops, conferences, and other programs for professional growth.
• Clinical Practice Planning: Organizes own time & sets priorities for a group of patients on a research protocol; plans research‑related activities while considering patient’s current medical problems; utilizes available resources to meet patient care needs; utilizes health‑care team members in planning care; coordinates care involving other disciplines to provide continuity and assist patient compliance with protocol requirements.
• Implementation: Assesses and ensures subject safety throughout trial participation; assists patients with medical problems related to study; recognizes common laboratory values and alerts appropriate