Research Nurse; BMG

Reports to the Nurse Manager, Clinical Research. Is responsible for the coordination and delivery of primary care to BMG research patients entered on clinical research studies. Provides support to the patient (and caregiver) throughout the continuum of care. Completes the evaluation, documentation, research and submission of data to the sponsoring group. Utilizes in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection to ensure compliance with protocol and regulatory requirements.

• MISSION:
  We deliver outstanding care, inspire health, and connect with heart.
• VALUES:
  Trust. Respect. Integrity. Compassion.
• SERVICE GOALS:
  Personally connect. Keep everyone informed. Be on their team.

• Assessing the eligibility of candidates for clinical research studies through a thorough review of the patient's history and physical, including hospital and clinical records.
• Coordinating the informed consent process in conjunction with the Physician, patient and their caregiver(s).
• Meeting with patient and caregivers to outline proposed study, time frame, study requirements and providing education on the diagnosis and proposed treatment.
• Continually monitoring study compliance through accurate documentation of toxicities and through the completion of treatment, which includes coordinating treatments, laboratory and radiological studies and other designated procedures for protocol compliance (serum and tissue submissions as required).
• Assessing adverse events and following up with the Physician, patient and sponsor as needed. Reporting all serious adverse events immediately to investigator and within 24 hours to sponsor. Also completing required documentation according to sponsor, regulatory and company policies.
• Following the Federal government guidelines with regard to assurances and Institutional Review Board (IRB) approval for research involving human subjects.
• Assessing the patient's physical status and, if necessary, ordering any study-required testing (such as radiology, labs, etc.) that has not yet been completed by the patient.
• Providing ongoing education to the patient and caregivers on the treatment (i.e., side effects of the treatment, when to seek assistance, what is serious, how to assess response to treatment) and encouraging ongoing dialogue with healthcare professionals.
• Ensuring ongoing communication with study participants to ensure their understanding of protocol and compliance - - for example, answering questions from the patient (or care giver) throughout the duration of the program.
• Coordinating compliance of procedures required by protocol through ensuring accurate communication between the investigator, patient, nurses, Memorial Hospital staff and Physician staff.
• Monitoring patients' medication dosages according to protocol requirements.
• Registering and randomizing eligible patients to consent research protocol study.
• Coordinating and monitoring the plan of care from assessment of eligibility to follow-up care after completion of protocol treatment. Also coordinating and monitoring the patient, Physician and protocol for complete compliance to plan of care.
• Coordinating, preparing and attending clinical monitoring visits. Also, ensures all appropriate clinical research protocols are completed 48 hours prior to monitoring visits.
• Serving as the primary contact for the sponsor or clinical research officer and resolves inquiries within required time frames.
• Conducting study closeout procedures according to sponsor specifications and company policies, including return of all study product.

• Submitting accurately completed protocol data to the sponsoring group in a timely manner as dictated by specific protocol.
• Checking for accuracy of the data submitted.
• Maintaining contact with clinical trial biostatistical centers to ensure data submission is accurate and timely.

• Maintaining records of study medications from cooperative centers for distribution to study participants. Also assisting Physicians in the distribution of protocol medications.
• Assisting with scheduled audits by cooperative groups or sponsoring pharmaceutical companies.
• Monitoring subjects who are (or have been) enrolled in clinical trials from their entry into the program through lifetime follow-up reports.
• Assisting the Physician, nurse and research team with determining clinical trial eligibility, protocol selection and treatment planning.
• Preparing reports as required by departmental guidelines.
• Completing other job-related assignments and special projects as directed.

• Attends and participates in department meetings and is accountable for all information shared.
• Completes mandatory education, annual…