Research Nurse; Oncology Job Baltimore area,Maryland USA,Healthcare

Position: 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.

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