Sr Research Nurse (Oncology)

We are seeking a Senior 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

• 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.

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.
• 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.

Recruitment & Enrollment

• 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.

Quality Assurance

• Evaluates outcomes of clinical trials.
• 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.

Patient/Family Education

• Designs/coordinates educational programs fo