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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 protocol.s

+ 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.

_Communications_

+ 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 or state where practicing. Bachelor's degree in nursing or related discipline required.

+ Minimum of two year's 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 strongly preferred.

Classified Title: Sr. Research Nurse

Role/Level/Range: ACRP/04/MF

Starting Salary Range: $75,100 - $131,700 Annually ($90,000 targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: Mon - Fri / 8:30am - 5p

FLSA Status: Exempt

Department name: SOM Onc Hematologic Malignancies

Personnel area: School of Medicine