Research Nurse (Oncology)

Reporting to the Research Nurse Manager, we are seeking a Research Nurse who will be responsible for the coordination and implementation of assigned clinical trials within the research program.

Specific Duties & Responsibilities

Project Management

Pre-study

• Anticipates research requirements for designated patient populations.
• With guidance, reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintenance of subject safety.
• With guidance, lists & clarifies concerns and questions about new protocols with PI and sponsor.
• Reviews prospective reimbursement analysis (PRA) as appropriate.

Pre-initiation

• As appropriate & with guidance, reviews consent forms prior to submission to the IRB.
• With guidance, prepares other forms required for study initiation (pre-printed orders, eligibility checklists, etc.)
• Determines that IRB approval has been received prior to initiation of research activity.
• Participates in study initiation meetings.
• Prepares space for study-related equipment & supplies.

Recruitment & enrollment

• Ensures initial & ongoing eligibility of all subjects for assigned research studies.
• Screens potential research subjects for participation in clinical trials (incl. Review of medical history, concomitant meds, pathology, other relevant documents).
• Evaluates ongoing eligibility of research subjects’ participation in clinical trials; collaborates with Principal Investigator to obtain exemptions as appropriate.
• Abstracts data from a variety of sources to complete pre-study work-up.
• Demonstrates and participates in the informed consent process.
• As appropriate, documents obtaining of informed consent in medical record.
• Registers research subjects per sponsor guidelines.
• In conjunction with PI, monitors protocol enrollment goals.
• Demonstrates knowledge of protocol endpoint definitions.
• In collaboration with healthcare team, evaluates potential subjects for research participation.

Data collection/Document maintenance

• Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials.
• Obtains & ensures proper distribution of required pharmacokinetic & tissue samples.
• Schedules, performs, and/or monitors procedures & tests per protocol requirements.
• Ensures correct documentation of clinical study in medical record and appropriate protocol documents.
• Schedules visits, tests & procedures for patients entered in clinical trials to ensure results are available in a timely manner.
• As appropriate, ensures all required signatures are obtained on informed consent documents.
• As appropriate, ensures validity of available informed consent documents.
• Maintains CRMS data base for enrollment.
• Reviews protocol amendments as required.
• Develops procedure and collection forms for pharmacokinetic sampling.
• With guidance & as dictated by research protocol, obtains required data through chart review, telephone communication, subject interview & assessment.
• Coordinates with data managers to ensure delivery of trial data for inclusion into study files.
• As appropriate, & with assistance as needed, orders required medical equipment & supplies.
• Maintains working knowledge of institutional information systems for correctly scheduling clinical tests & procedures and extracting data.
• With guidance, organizes own time & sets priorities for research-related functions.
• With guidance, able to prioritize workload & manage multiple projects effectively.
• Achieves and maintains a working knowledge of computer software specific to department, including word processing, e-mail & internet functions.
• Aware of & knowledgeable about departmental Standard Operating Procedures.

Quality Assurance

• Evaluates outcomes of assigned clinical trials.
• Recognizes and documents adverse events per protocol & ensures reporting to appropriate study & regulatory personnel; with guidance, initiates adverse event reports and ensures proper and timely distribution to sponsor and IRB.
• Grades identified toxicities per NCI or protocol-specific criteria.
• Attends medical staff meetings to review study progress.
• In collaboration with other members of the research team, prepares for and responds to study audits.

Communication

• With guidance, assists in completion of annual periodic