We are seeking a Sr Research Nurse to work under the Nurse Manager and/or the Lead Research Nurse. This position is responsible for coordinating and implementing assigned clinical trials within the Breast Cancer and Female Malignancies 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.
- Evaluate 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 or state where practicing.
- Bachelor's Degree in nursing or related discipline required.
- Master's Degree strongly preferred.
- 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.
Classified Title: Sr. Research Nurse Role/Level/Range: ACRP/04/MF Starting Salary Range: $75,100 - $131,700 Annually ($103,400 targeted; Commensurate with experience) Employee group: Full Time Schedule: M - F, 8:30 - 5:00 pm Exempt Status:Exempt Location:Hybrid/School of Medicine Campus Department name: SOM Onc Breast & Gyn Malignancies Group Personnel area: School of Medicine
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