CO Sr. Research Nurse

We are seeking a CO Sr. Research Nurse to Report to the Senior Division Manager, Nurse Manager and or the Lead Research Nurse, this position is 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 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 time frames.

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.