Reporting to the Senior Division Manager, Nurse Manager, and/or the Lead Research Nurse, we are seeking a
Sr. Research Nurse who will be responsible for the coordination and implementation of assigned clinical trials within the research program.
Specific Duties & ResponsibilitiesProject Management
Pre-study
- Collaborates in development and preparation of regulatory documents as appropriate including consent templating and eligibility checklist.
- 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, and maintaining subject safety.
- Evaluates the impact on & availability of resources for assigned clinical trials.
- Lists, clarifies concerns, and questions about new protocols with the PI and/or sponsor
- Proposes and 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.
- Assures pharmacy access to inventory management systems for sponsors.
- 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.
- Provides copy of study and pre-printed data forms to Data Management office for review and approval as appropriate.
- Assures receipt of protocol by pharmacy for review & input 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, 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 and Enrollment
- Ensures initial & ongoing eligibility of all subjects for each assigned research studies.
- Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes.
Data Collection/Documentation maintenance
- 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
- 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.
- Maintains records of correspondence of faxes, emails, IRB/JCCI submissions, FDA submissions.
Patient/Family Education
- Designs & coordinates educational tools for patients and families relevant to protocols.
- Provides ongoing education to patients & families regarding pertinent clinical trial procedures and management of clinical care.
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.
Minimum Qualifications- Must be a Registered Nurse, licensed in the State of Maryland or state where practicing.
- Bachelor's Degree in Nursing or related discipline.
- Two years' experience in the specialty or a related area.
- Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Preferred QualificationsClassified Title: Sr. Research Nurse
Role/Level/Range: ACRP/04/MF
Starting Salary Range: $75,100 - $131,700 Annually ($103,400 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Mon - Fri / 8:30a - 5p
FLSA Status: Exempt
Location: School of Medicine Campus
Department name: SOM Onc Cancer Immunology/GI Clinical Re
Personnel area: School of Medicine
