Sr. Research Nurse

The Office of Capital Region Research (CAPRES) is a Johns Hopkins Medicine effort that provides research management and support infrastructure to the Johns Hopkins-owned hospitals in the National Capital corridor. CAPRES is seeking a full time Sr. Research Nurse to work at Suburban Hospital in Bethesda, Maryland. 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 Director, CAPRES.

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 regar