Reporting to the Senior Division Manager, Nurse Manager and or the Lead Research Nurse, we are seeking a Sr. 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 * Collaborates in development and preparation of regulatory documents as appropriate including consent templating, eligibility checklist, PK/VS/EKG sheets. * 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. * Obtains appropriate data base/electronic data capture training and access. * Oversees & collaborates in development of study tools including data collection forms, eligibility checklists, Beacon orders, & distribution of the protocol on the Web Library and Internet (where applicable). * Sets up/assures set up of appropriate research study accounts/ reviews PRA. * Assures receipt of protocol and other manuals/documents to clinical CORES for review & input as appropriate. * Assures study documents are uploaded into PRL website for Beacon Treatment Plan development for both new submissions and amendments. * Assures compliance with local & national regulatory standards; as appropriate, prepares & submits required regulatory documents. * May participate in drug data sheet development/review/revision. * Monitors for IRB approval/request for further information as appropriate. * Determines that IRB approval has been received and study status is Active on CRO protocol library prior to initiation of research activity. * Represents department at research, investigator and protocol initiation meetings as required. * Assures that all elements of a trial are in place before opening to accrual. * Communicates with protocol sponsors, NCI, cooperative group and may coordinate plans to address issues with PI. Recruitment & enrollment * Ensures initial & ongoing eligibility of all subjects for assigned research studies. * Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes. Data collection/Document maintenance * Applies pharmacological knowledge to assist the investigator in determining adverse event causality & relationship to study drug/procedure. * Assures accurate recording & documentation of 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 * 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. * Participates in sponsor/cooperative group/internal audits/monitoring. * Assures correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc. are in the regulatory binder/files. Communication * Communicates effectively with study team members, CORES, clinical staff, patients and families. Patient/Family Education * Designs/coordinates educational education and tools for patients and families relevant to protocols. * Provides ongoing education to patients and families regarding pertinent clinical trial procedures and management of clinical care. Staff Education * With assistance, coordinates and/or presents continuing education/in-service programs for Clinical Research Nurses, Clinical Nurses, Clinical Associates, Study Coordinators, Research/Standard of care Phlebotomists, and any others involved in the research process. Professional Development * 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. 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 and clinical care for assigned clinical trials. * Begin to manage multi-modality trials utilizing current treatment modalities. Evaluation * Evaluates the effectiveness of nursing care s/he has planned, administered, or delegated. * Evaluates patient's response to interventions outlined on study protocol. * Proposes alternative methods to meet individual patient needs and protocol requirements. * 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 patients 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. * Minimum of two years 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. * * * Classified Title: Sr. Research Nurse Role/Level/Range: ACRP/04/MF Starting Salary Range: $76,980 - $134,998 Annually ($105,985 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: Mon - Fri / 8a - 4:30p FLSA Status: Exempt Location: School of Medicine Campus Department name: SOM Onc Urologic Oncology Personnel area: School of Medicine