Sr Research Nurse (Oncology)

We are seeking a Senior 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. * May collaborate in development & writing of protocols and consent forms, as appropriate. * Collaborates in development and preparation of regulatory documents as appropriate. * Applies knowledge of study design to evaluate new protocols. * Applies knowledge of federal & local regulations when evaluating new protocols. * Reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety, etc. * Evaluates the impact on & availability of resources for assigned clinical trials. * Lists & clarifies concerns & questions about new protocols with PI &/or sponsor Proposes & negotiates alternatives to improve protocol implementation. Pre-initiation * Collaborates in the determination of roles & responsibilities of health care team members in the implementation of assigned trials. * Collaborates in the design of appropriate methods for collection of data required for assigned trials. * Oversees & collaborates in development of study tools including data collection forms, eligibility checklists, preprinted orders, & distribution of the protocol on the Web Library and Internet (where applicable). * Assists with preparation of budget for submission and coordinates study sponsor contract designation as appropriate. * Provides copy of study and pre-printed data forms to Data Management office for review and approval as appropriate. * Prepares GCRC and PCRU protocol submissions as appropriate. * Assures receipt of protocol by pharmacy for review & input as appropriate. * Communicates with coordinating center and provides necessary documentation (i.e., CVs, 1572, lab licenses, normal values, IRB submissions, etc.) as appropriate. * Assures compliance with local & national regulatory standards; as appropriate, prepares & submits required regulatory documents. * Prepares drug data sheets for pharmacy and assures submission of same to CRO/IRB for assigned protocols as appropriate. * Monitors for and notifies PI of IRB approval/request for further information as appropriate. * Determines that IRB approval has been received prior to initiation of research activity. * Represents department at research and protocol initiation meetings. * Assures that all elements of a trial are in place before opening to accrual. * Communicates with protocol sponsors, NCI, cooperative group and coordinates plans to address issues with PI. Recruitment & Enrollment * Ensures initial & ongoing eligibility of all subjects for assigned research studies: Same as Level I. * Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes. Data collection/Document maintenance * Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials. * Applies pharmacological knowledge to assist the investigator in determining adverse event causality & relationship to study drug/procedure. * Records & documents protocol deviations. * Prepares and submits protocol amendments and revisions as appropriate. * Demonstrates ability to manage multiple projects at different stages of the clinical research process. * Demonstrates ability to integrate new clinical trials with current research activity. Quality Assurance * Evaluates outcomes of clinical trials. * Monitors study team compliance with required study procedures & GCP standards. * Performs/monitors ongoing data analysis regarding clinical research studies, including toxicities, dose modifications, dose levels, adverse reactions, & response. * Assumes responsibility for specific QA activities for research teams (i.e., participates in institutional QA process). * Participates in sponsor/cooperative group/internal audits/monitoring. * Assists with development & review of institutional SOPs pertaining to performance of clinical research. * Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc. Patient/Family Education * Designs/coordinates educational programs for patients and families relevant to protocols. * Provides ongoing education to patients and families regarding pertinent clinical trial and clinical management issues. Staff Education * Participates in orientation process for new Clinical Research Nurses and Clinical Associates, including mentoring and precepting. * Coordinates and/or presents continuing education/in-service programs for Clinical Research Nurses, Clinical Associates, Data Managers, and others involved in the research process. * Attends and participates in in-service and external trainings, workshops, conferences, and other relevant programs for professional growth and development. Community * Collaborates with other members of the research team in preparing study results for presentation/publication. * Authors/coauthors manuscripts for publication in the nursing literature and/or presentation at conferences related to areas of expertise. * Identifies nursing research questions related to protocol populations/issues and, with assistance, collaboration, and appropriate financial support, implements nursing research within departmental priorities. * Takes advantage of opportunities to make presentations in local community regarding research projects, areas of expertise, etc. Clinical Practice Planning * Identifies need and incorporates information from other health care disciplines into clinical research protocol. * Plans long-term study patient care in relation to identified and potential problems related to assigned research protocols/patient populations. Implementation * Collaborates with health care team to coordinate and facilitate protocol requirements for assigned clinical trials. Evaluation * Evaluates the effectiveness of nursing care planned, administered, or delegated. * Evaluates patient's response to interventions outlined on study protocol. * Proposes alternative methods to meet individual patient needs. * Evaluates effectiveness of nursing care planned on a long-term basis. * Gives rationale for action/inaction based on scientific principles, practice experience, and internal/external regulations. * Evaluates patient's participation in assigned clinical trials and identifies barriers to compliance. * Plans, proposes and evaluates means to overcome identified barriers to protocol compliance. Consultation * Develops and maintains collaborative relationships with members of other health care disciplines in order to facilitate clinical and research outcomes. * Provides guidance and direction to other health care professionals (internal and external) in implementation of research protocols. * Evaluates effectiveness of collaborative role with other health care professionals. Minimum Qualifications * Individual must be a registered nurse, licensed in the State of Maryland. * Bachelor's Degree in Nursing or related discipline. * Two years of experience in the specialty or a related area required. * Additional experience may substitute for bachelor's degree and related master's degree may be considered in lieu of experience Preferred Qualifications * Master's Degree * * * Classified Title: Sr. Research Nurse Role/Level/Range: ACRP/04/MF Starting Salary Range: $75,100 - $131,700 Annually ($103,400 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: Mon - Fri / 8a - 5:30p FLSA Status: Exempt Location: School of Medicine Campus Department name: 10002935-SOM Onc Hematologic Malignancies Personnel area: School of Medicine