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.

• 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 

About Johns Hopkins University

Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.

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