Sr. Research Nurse (Oncology)

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 & 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 protocol.s
• 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.

Communications

• 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 Phlebot