Reporting to the Sr. Clinical Research Program Manager and the Vice Chair for Clinical Research, we are seeking a Sr. Research Nurse who will be responsible for the coordination and implementation of assigned clinical trials within the research program. The Sr. Research Nurse is recognized as having expertise in radiation oncology pertaining to a variety of disease sites, clinical research compliance and operations, IT systems, working closely with other research nurses and staff in carrying out the department's clinical trials.

Specific Duties & Responsibilities

Pre-study

• Collaborates in development and preparation of research and administrative documents as appropriate including consent forms, eligibility checklist, requests for the use of Core Services.
• Membership on the Radiation Oncology Clinical Trials Review Committee, applying knowledge of study design and departmental workflow to evaluate and participate in the development of new protocols.
• Reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety.
• Evaluates the impact on and availability of resources for assigned clinical trials.
• Lists and clarifies concerns and questions about new protocols with PI &/or sponsor.
• Proposes new alternatives to improve protocol implementation.

Pre-initiation

• Collaborates in the design of appropriate methods for collection of data required assuring short- and long-term objectives are captured.
• Obtains appropriate data base training/electronic data capture and access.
• Participates in reviewing PRAs and OnCore Calendars.
• Assures receipt of protocol and other manuals/documents to clinical CORES for review and input as appropriate.
• Determines that IRB approval has been received and study status is Active on CRO protocol library prior to initiation of research activity.
• Represents department at research, investigator, and protocol initiation meetings.
• Assures that all elements of a trial are in place before activation of trial.
• Communicates with the PI and Sr. Clinical Research Program Manager and research coordinators to address any study issues.

Recruitment & enrollment

• Ensures initial and ongoing eligibility of all subjects for assigned research studies.
• Develops recruitment strategies to ensure patient accrual within protocol timeframes.
• Attends meeting/conferences where patients may be identified as a potential study participant.

Data collection/Document maintenance

• Ensures collection of pertinent data from internal and external sources and ensures compliance with requirements of assigned clinical trials.
• Identifies adverse events with Study team and assists in the completion of AE logs so that the PI can assign causality.
• Works with the PI and study team to ensure accurate recording and documentation of protocol deviations.
• Demonstrates ability to manage and prioritize 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 as per study protocol.
• Monitors ongoing data regarding clinical research studies, including toxicities, dose modifications, dose levels, and adverse reactions.
• Assists with development and review of departmental SOPs pertaining to performance of clinical trials group.
• Maintains knowledge of new IRB processes.

Communication

• Independently performs responsibilities with a high level of professionalism with staff, colleagues, patients and others.
• Collaborates well within the clinical trials group, department, and outside entities.

Education

• Provides ongoing education to patients and families regarding pertinent clinical trial protocols.
• Participates and coordinates orientation process for new Research Nurses and clinical research staff.
• Coordinates and/or presents continuing education/in-service programs for Clinical Research Nurses and any others involved in the research process.

Professional Development

• Attends and participates in in-service and external trainings, workshops, conferences, and other relevant programs for professional growth and development.

Evaluation

• Evaluates patient's response to interventions outlined on study protocol.
• Proposes alternative methods to meet individual patient needs.
• Evaluates patient's participation in assigned clinical trials and identifies barriers to compliance.
• Plans, proposes and evaluates means to overcome identified barriers to protocol compliance.
• Ability to be involved in manuscript, poster presentation, abstract including authorship.

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.

Minimum Qualifications

• Registered Nurse, licensed in the State of Maryland
• Two years of experience in the specialty or a related area.
• Current CPR certification.
• Must maintain current licensure and certification for duration of employment.
• Completion of the JHH credentialing process is required prior to start date.
• Additional education may substitute for required experience to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Master's Degree
• General computer skills with knowledge of Microsoft Office (Word, Excel, Teams), EPIC, REDCap, OnCore, and other systems used only in Radiation Oncology such as Mosaiq and OncoBrowser.