Sr. Research Nurse (Office of Clinical Trials)

CAPRES (Capital Region Research) is seeking a full-time Sr. Research Nurse to work at Suburban Hospital in Bethesda, Maryland, and the nearby Sibley Memorial Hospital in Washington, DC. The Sr. Research Nurse will work with multiple Principal Investigators to perform the responsibilities inherent in clinical research studies and will report directly to the Office of Clinical Trials, Director of Research Operations.

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 and 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 and the review of the internal budget.
• Prepares 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 and coordinates 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

• 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 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.
• Communication: Independently/collaboratively performs responsibilities of Level I

Education

• 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 staff including mentoring and preceptoring.
• 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.
• 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 s/he has planned, administered, or delegated.
• Evaluates patients' 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 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.

Clinical Responsibilities

• Perform clinical duties as assigned.

Supervisory Responsibilities

• Provides supervision and oversight of Clinical Associates as assigned.

• The individual must be a registered nurse, licensed in the State of Maryland at the time of hire.

• The individual must obtain a registered nurse license in the District of Columbia within 90 days of hire.

• Minimum of two year's experience in the specialty or a related are required.

Classified Title: Sr. Research Nurse
Job Posting Title (Working Title):Sr. Research Nurse (Office of Clinical Trials)
Role/Level/Range: ACRP/04/MF
Starting Salary Range: $75,100 - $131,700 Annually ($100,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: 37.5/ M-F 8:30 am - 5 pm
FLSA Status:Exempt
Location: JH at Bethesda
Department name: SOM Admin Res Clinical Research Contract
Personnel area: School of Medicine