Sr. Research Nurse (Oncology)

Specific Duties & Responsibilities

Project Management

Pre-study

• Collaborates in development and preparation of regulatory documents as appropriate including consent templating, eligibility checklist, PK/VS/EKG sheets
• 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.

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.
• 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
• Assures receipt of protocol and other manuals/documents to clinical CORES for review & input as appropriate
• Assures study documents are uploaded into PRL website for Beacon Treatment Plan development for both new submissions and amendments
• Assures compliance with local & national regulatory standards; as appropriate, prepares & submits required regulatory documents
• May participate in drug data sheet development/review/revision
• Monitors for IRB approval/request for further information 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 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 & 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:
• Applies pharmacological knowledge to assist the investigator in determining adverse event causality & relationship to study drug/procedure
• Assures accurate recording & documentation of 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.
• Assures correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc. are in the regulatory binder/files.

Communication

• Communicates effectively with study team members, CORES, clinical staff, patients and families.

Patient/Family Education

• Designs/coordinates educational education and tools for patients and families relevant to protocols.
• Provides ongoing education to patients and families regarding pertinent clinical trial procedures and management of clinical care.

Staff Education

• With assistance, coordinates and/or presents continuing education/in-service programs for Clinical Research Nurses, Clinical Nurses, Clinical Associates, Study Coordinators, Research/Standard of care Phlebotomists, 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.

Community

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

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.
• Begin to manage multi-modality trials utilizing current treatment modalities.

Evaluation

• 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 and protocol requirements.
• 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.

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.
• Evaluates effectiveness of collaborative role with other health care professionals.

• Individual must be a registered nurse, licensed in the State of Maryland
• Minimum of two years experience in the specialty or a related area required.

Classified Title: Sr. Research Nurse
Job Posting Title (Working 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 - 5pm
FLSA Status:Exempt
Location: School of Medicine Campus
Department name: SOM Onc Hematologic Malignancies
Personnel area: School of Medicine