Sr. Research Nurse (Office of Clinical Trials)

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