Sr. Research Nurse (Oncology)

Johns Hopkins University•Baltimore, MD

3d•Onsite

About The Position

Reporting to the Senior Division Manager, Nurse Manager, and/or the Lead Research Nurse, this role is responsible for the coordination and implementation of assigned clinical trials within the research program. The position involves project management from pre-study through enrollment and data collection, ensuring quality assurance, and providing education to patients, families, and staff.

Requirements

Must be a Registered Nurse, licensed in the State of Maryland or state where practicing.
Bachelor's Degree in Nursing or related discipline required.
Minimum of 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.

Nice To Haves

Master's Degree

Responsibilities

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.
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.
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.
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.
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.
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.
Attends and participates in in-services and external training, workshops, conferences, and other relevant and/or required programs for professional growth and development.
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.
Collaborates with health care team to coordinate and facilitate protocol requirements and clinical care for assigned clinical trials.