Sr. Research Nurse

We are seeking a Sr. Research Nurse who will report to the Principal Investigator(s), Research Nurse Manager, and Lead Research Nurse. This position is responsible for the coordination and implementation of assigned clinical trials within the Developmental Therapeutics Program.

Specific Duties & Responsibilities

Project Management

• Pre-study 
• Anticipates research requirements for designated patient populations.
  
• May collaborate in the development & writing of protocols and consent forms, as appropriate.
• Collaborates in the 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.
• Evaluate 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 healthcare team members in the implementation of assigned trials.
• Collaborates in the design of appropriate methods for collecting data required for assigned trials.
• Oversees & collaborates in the development of study tools including data collection forms, eligibility checklists, preprinted orders, & distribution of the protocol on the Web Library and Internet (where applicable).
• Assures receipt of a protocol by the pharmacy for review & input as appropriate.
• Assures compliance with local & national regulatory standards.
• Collaborates with the study team and pharmacy to prepare drug data sheets for new trials.
• Determines that IRB approval has been received before initiation of research activity.
• Represents the 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, and cooperative groups, and coordinates plans to address issues with PI.
• Works with CBT on beacon protocol order sets before start-up and attends institutional PORSCHE meetings to approve electronic order sets.

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 the study drug/procedure.
• Manages patients on clinical studies while adhering to all protocol mandates and standard of care clinical practice.
• Assures all clinical protocol deviations are communicated with the team for proper documentation and or submission to regulatory agencies.
• 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.
• Works with CBT on beacon protocol order set changes with amendments that require adjustment to the original order set plan.
• 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, & responses.
• 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 the development & review of institutional SOPs about the performance of clinical research.
• Maintains records of correspondence of faxes, e-mails, IRB/JCCI submissions, FDA submissions, etc.

Communication

• Independently/collaboratively performs responsibilities of Level I
• Collaborate closely with the study coordinator on patient updates and clinical issues to ensure prompt, accurate reporting to sponsors or other entities is handled wit