The Department of Radiation Oncology is seeking a Sr. Research Nurse who will be responsible for the coordination and implementation of assigned clinical trials within the research program. As part of the study team, the Sr. Research Nurse collaborates with faculty, develops protocol, develops SOP, and oversees study-related activities for one or more studies.

Specific Duties & Responsibilities

• 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 resources for assigned clinical trials.

• Lists & clarifies concerns & questions about new protocols with PI &/or sponsor.

• Proposes & 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.

• Oversees & collaborates in development of study tools including data collection forms, eligibility checklists, preprinted orders, & distribution of the protocol on the Web Library and Internet (where applicable).

• Assists with preparation of budget for submission and coordinates study sponsor contract designation as appropriate.

• Provides copy of study and pre-printed data forms to Data Management office for review and approval as appropriate.

• Prepares GCRC and PCRU 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, NCI, cooperative group and coordinates plans to address issues with PI.

• Ensures initial & ongoing eligibility of all subjects for assigned research studies: Same as Level I.

• 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.

• Performs blood draws if needed per protocol.

• Supervises patients and their designee in completing surveys and questionnaires per protocol.

• Collaborates with neuropsychology teams to ensure neurocognitive testing is completed per protocol.

• 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/cooperative group/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.

• 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.

• Participates in orientation process for new Clinical Research Nurses and Clinical Associates, including mentoring and precepting.

• Coordinates and/or presents continuing education/in-service programs for Clinical Research Nurses, Clinical Associates, Data Managers, and others involved in the research process.

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

• Collaborates with other members of the research team in preparing study results for presentation/publication.

• Authors/coauthors manuscripts for publication in the nursing literature and/or presentation at conferences related to areas of expertise.

• 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.

• 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 for assigned clinical trials.

• Evaluates the effectiveness of nursing care s/he has planned, administered, or delegated.

• Evaluates patient's 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.

Special Knowledge, Skills & Abilities

• Demonstrated knowledge of computer applications and databases and of personal computer systems is highly desirable.

• Ability to demonstrate knowledge and skills necessary to provide care appropriate to the age of the patients served.

• The individual must demonstrate knowledge of the principles of growth and development over the lifespan and possess the ability to assess data reflective of the patients’ requirements relative to his or her age-specific needs, and to provide the care needed as described in the unit/area/department policies and procedures.

• Knowledge of investigational therapies which require special expertise and clinical care management.

• Highly effective verbal and written communication skills are required.

Minimum Qualifications

• Bachelor's Degree in Nursing or related discipline required.

• Licensed Registered Nurse in Washington D.C. and the state of Maryland.

• Minimum of two year's experience in the specialty or a related area required.

• Additional experience may substitute for bachelor's degree and related master's degree may be considered in lieu of experience.

• Current CPR certification required.

• Must maintain current licensure and certification during duration of employment.

• Completion of the Sibley credentialing process is required prior to start date.

Preferred Qualifications

• Master's Degree strongly desired.

Classified Title: Sr. Research Nurse

Role/Level/Range: ACRP/04/MF

Starting Salary Range: $74,400 - $130,400 Annually ($90,000 targeted; Commensurate with experience)

Employee group: Full Time

Schedule: M-F, 8:30am-5:00pm

Exempt Status: Exempt

Location: District of Columbia

Department name: ​​​​​​​SOM Rad Onc Clinical Trials Group

Personnel area: School of Medicine

Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.