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 and eligibility checklist. * 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, and maintaining subject safety. * Evaluates the impact on & availability of resources for assigned clinical trials. * Lists, clarifies concerns, and questions about new protocols with the PI and/or sponsor * Proposes and 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. * Assures pharmacy access to inventory management systems for sponsors. * 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. * Provides copy of study and pre-printed data forms to Data Management office for review and approval as appropriate. * Assures receipt of protocol by pharmacy for review & input 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, 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 and Enrollment * Ensures initial & ongoing eligibility of all subjects for each assigned research studies. * Collaborates in the development of recruitment strategies to ensure patient accrual within protocol timeframes. Data Collection/Documentation maintenance * 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. 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. * Maintains records of correspondence of faxes, emails, IRB/JCCI submissions, FDA submissions. Patient/Family Education * Designs & coordinates educational tools for patients and families relevant to protocols. * Provides ongoing education to patients & families regarding pertinent...