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Research Nurse
2 months ago
Job Title: Research Nurse - Clinical Trials Specialist
Company: Tennessee Oncology
Job Summary:
We are seeking a highly motivated and detail-oriented Research Nurse to join our team at Tennessee Oncology. As a Research Nurse, you will play a critical role in the success of our clinical trials program, ensuring the highest level of patient care and protocol compliance.
Key Responsibilities:
- Screen, enroll, and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study.
- Obtain and maintain informed consents of each patient for the duration of a study.
- Review the study design and inclusion/exclusion criteria with physician and patient.
- Ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements.
- Complete and document screening/eligibility accurately.
- Complete and document the informed consent process accurately and have all parties sign/date as required, including HIPAA Authorization.
- Accurately complete and submit on-study forms within required timelines.
- 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.
- Ensure that patient documentation is completed at each clinic visit while in screening.
- Ensure that all medications are approved prior to initiating treatment or when changing medication regimens, such as crossover studies.
- 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.
- Provide patient education and medical information to study patients to ensure understanding or proper medication dosage, administration, and disease treatment.
- Maintain medication inventory and reconciliation.
Requirements:
- Knowledge of medical and research terminology.
- Knowledge of FDA Code of Federal Regulations and GCP.
- Knowledge of the clinical research processes.
- At least one year of oncology experience, preferably hematology and/or transplant.
- At least one year of experience in a research setting preferred.
- Research Certification (ACRP or CCRP) Preferred.
Education & Experience:
- An Associate Degree; preferably a bachelor's degree.
- RN License.
