GENERAL SUMMARY OF DUTIES
- Research Nurse- (Oncology experience preferred)
DUTIES INCLUDE BUT ARE NOT LIMITED TO:
- Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and close monitoring while the subjects are on study. Responsible for all data collection, source documentation and submission of adverse experience reports.
eligible subjects according to protocol requirements.
- Supports enrolling patients onto oncology clinical trials through recruitment, screening, enrollment and follow up of
within the timeframe specified by the study manager.
- Ensures the protection of study patients by timely adherence to protocol requirements/compliance
- Attends monthly staff meetings and participates in site initiation visits as required or asked to do so.
- Maintains patient confidentiality according to ethical and legal requirements.
- Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement".
- Adheres to appropriate Standard Operating Procedures
- Be familiar with the protocols on which the patients are enrolled
- Use the protocol as the only tool to screen, treat, and follow patients
- Reviews the study design and inclusion/exclusion criteria with physician and patient.
- Complete and document screening/eligibility accurately
- Complete and document the informed consent process accurately and have all parties fully execute the document including HIPAA Authorization
- Complete the inclusion/exclusion form and standard enrollment form accurately
- Accurately complete and submit the on-study forms within two weeks of enrollment for investigator-initiated protocols
- Assess the patient and document findings at each clinic visit while on protocol
- Document all specific tools required by the protocol (i.e. oral medication forms, pill count diaries, quality of life questionnaires, neuro exams, vital signs sheets, times of PK draws, etc.)
- Screen every new patient or patient returning to office with scan results and document appropriately on the patient tracking logs
- Complete the study medication order form accurately and have the physician or nurse practitioner sign orders prior to treatment
- Ensure that all medications, including antiemetics, are approved by the registrar prior to initiating treatment or when changing medication regimens, such as crossover studies
- Accurately calculate and document the BSA, creatinine clearance, urine protein: creatinine ratio or any other conversions needed per protocol
- Document any interaction regarding the patient that occurs while the patient is enrolled on a protocol, including follow-up and survival (this includes home health intervention, pharmacies, study managers, physicians, and clinic personnel)
- Ensure that follow-up appointments, scans, or any related procedures are scheduled correctly according to protocol requirements
- Inform and document appropriate SCRI personnel when patient comes off study
- Accurately complete all data and query requests and submit with source documentation
Reconsent patients in a timely manner and document process appropriately
- Obtain completed and signed waivers prior to submitting forms to enrollment coordinator for investigator-initiated protocols
- Accurately complete the deviation/violation form as soon as event becomes apparent
- Accurately completes initial SAE report and submits to the Safety Department within 24 hours of becoming aware of the event
- Accurately completes and submits follow-up SAE report to the Safety Department within the timeframe allotted by the Regulatory Department.
KNOWLEDGE, SKILLS, & ABILITIES
- This position requires the following minimal requirements:
- Working knowledge of medical and oncology research terminology
- Working knowledge of federal regulations, good clinical practices, (GCP).
- Ability to communicate and work effectively with a diverse team of professionals.
- Ability to work with minimal supervision at offsite facilities.
- BS in nursing, pharmacy or other related science or combination of equivalent education and experience.
- 2 years clinical experience or
- 4 years clinical research experience.
- Current RN. License to practice in the state of Tennessee
- OCN certification preferred
- Current BCLS certification
- Current ACRP certification preferred