Early Phase Research Nurse

Tennessee Oncology•Nashville, TN

About The Position

Tennessee Oncology is seeking a dedicated and detail-oriented Early Phase Research Nurse to join our team. In this role, you will be responsible for screening, enrolling, and following study subjects, ensuring rigorous protocol compliance, and providing close monitoring throughout their participation in the clinical trial. Your role will be critical in maintaining the integrity of the studies and ensuring the safety and well-being of all participants.

Requirements

Knowledge of medical and research terminology
Knowledge of FDA Code of Federal Regulations and GCP
Knowledge of the clinical research processes
An Associate Degree; preferably a bachelor’s degree
RN License
Minimum of 5 years of clinical oncology nursing experience required, with 1 year of experience clinical research, particularly in Phase 1 trials
ACRP certification required within 6 months of meeting certification requirements.

Responsibilities

Facilitate the informed consent process and enroll eligible participants into clinical trials. You will complete and document the informed consent process accurately and has all parties sign/date as required, including HIPAA Authorization.
Conduct initial screening of potential study subjects to determine eligibility based on study criteria.
Conduct and coordinate pharmacokinetic studies, including the collection of biological samples such as blood, urine, and saliva for pharmacokinetic analysis. You will review the study design and inclusion/exclusion criteria with physician and patient. You will complete and document screening/eligibility accurately.
Monitor participants throughout the study to ensure adherence to the protocol. You will accurately complete and submit on-study forms within required timelines. You will 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.)
Track and document patient progress, including any adverse events, and ensure timely reporting as required by the study protocol.
Complete eligibility screening for all new patient or patients returning to office with scan results and document appropriately on the patient tracking logs.
Dispense oral investigation products as required by the study protocol.
Accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol.
Ensure that follow-up appointments, scans, or related procedures are scheduled correctly according to protocol requirements.
Document appropriately when patients are removed from protocol.
Ensure reconsent of patients at the next scheduled visit, following availability of updated ICF, and documents process appropriately.
Monitor and ensure patient compliance with investigation medications, providing education and support as needed.
Work closely with the research team, including principal investigators and coordinators, to support study objectives.
Communicate effectively with study subjects, addressing any questions or concerns they may have.