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Posted: Wednesday, July 5, 2017 12:28 PM

The Department of Oncology (Pediatric Oncology) is seeking a Research Nurse. Reporting to the Research Nurse Manager, this position is responsible for the coordination and implementation of assigned clinical trials within the research program.Duties and Responsibilities:Project ManagementPre:study:Anticipates research requirements for designated patient populations. With guidance, reviews and assesses new protocols for clarity, thoroughness, logistical feasibility, maintenance of subject safety. With guidance, lists and clarifies concerns and questions about new protocols with PI and sponsor. Reviews prospective reimbursement analysis (PRA) as appropriate.Pre:initiation:As appropriate and 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 and supplies.Recruitment and Enrollment: Ensures initial and 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 subjectsA? 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 and external sources and monitors compliance with requirements of assigned clinical trials. Obtains and ensures proper distribution of required pharmacokinetic and tissue samples. Schedules, performs, and/or monitors procedures and tests per protocol requirements. Ensures correct documentation of clinical study in medical record and appropriate protocol documents. Schedules visits, tests and 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 and as dictated by research protocol, obtains required data through chart review, telephone communication, subject interview and assessment. Coordinates with data managers to ensure delivery of trial data for inclusion into study files. As appropriate, and with assistance as needed, orders required medical equipment and supplies. Maintains working knowledge of institutional information systems for correctly scheduling clinical tests and procedures and extracting data. With guidance, organizes own time and sets priorities for research:related functions. With guidance, able to prioritize workload and manage multiple projects effectively. Achieves and maintains a working knowledge of computer software specific to department, including word processing, e:mail and internet functions. Aware of and knowledgeable about departmental Standard Operating Procedures.Quality Assurance:Evaluates outcomes of assigned clinical trials. Recognizes and documents adverse events per protocol and ensures reporting to appropriate study and regulatory personnel; with guidance, initiates adverse event reports and ensures proper and timely distribut

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• Location: Baltimore

• Post ID: 24068978 baltimore
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