Sr Research Nurse; Oncology

Position: 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 time frames.

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 for patients and families relevant to protocols.

* Provides ongoing education to patients and families regarding pertinent clinical trial and clinical management issues.

Staff Education

* Participates in orientation process for new Clinical Research Nurses and Clinical Associates, including mentoring and precepting.

* Coordinates and/or presents continuing education/in-service programs for Clinical Research Nurses, Clinical Associates, Data Managers, and others involved in the research process.

* Attends and participates in in-service and external trainings, workshops, conferences, and other relevant programs for professional growth and development.

Community

* Collaborates with other members of the research team in…