Clinical Research Nurse

Job Description

Job Description:

The Clinical Research Nurse will be able to function as a Clinical Research Coordinator and shall assist primary investigators with the following tasks in order to develop institutionally‐approved research protocols:

• Identify the appropriate forms and processes necessary to complete the research protocol.
• Refine the specific aims, research question hypothesis and/or objectives of the proposed study.
• Coordinate statistical and scientific consultation from CIF staff.
• Develop an individualized timeline for each protocol.
• Complete the necessary documents for approval, including the informed consent, recruitment materials, and data collection forms.
• Coordinate administrative, IRB, and/or IACUC (Institutional Animal Care and Use Committee) approval of proposed research protocols.
• Must Obtain and maintain NIH and CITI training in accordance with local IRB policy.
• Organize and prioritize all activities associated with conducting phase I, II and III clinical trials and clinical studies within a military setting.
• Review and understand biomedical research protocols, ensuring applicable regulations and guidelines are followed.
• Develop source documents for assigned studies, manage data collection, and ensure all Adverse Events (AEs) are identified and reported appropriately.
• Enter required data on paper or electronic case report forms (CRFs), audit records for accuracy, resolve discrepancies, and correct as necessary.
• Collect, organize and maintain all essential documents required for study regulatory files.
• Coordinate with external monitors and internal quality assurance to assure compliance with protocol, Standard Operating Procedures (SOPs), regulations and guidelines.
• Conduct protocol evaluation and feasibility assessment of proposed clinical research.
• Prepare relevant documentation for submission to the Institutional Review Board (IRB).
• Develop patient information and informed consent forms and patient recruitment materials.
• Meet with potential research subjects to explain the research project in detail and enroll eligible subjects into the study by obtaining written informed consent.
• Communicate with the IRB point of contact (POC); as required, in order to maintain protocol renewals and meet any and all interim reporting requirements.
• Provide internal assessment of adherence to approved protocols, as well as all relevant DoD and FDA regulations, under guidance of the Principle Investigator (PI).
• Obtain and maintain NIH and CITI training in accordance with local IRB policy.
• Support the oversight of the CIF’s quality assurance program to ensure compliance with applicable rules and regulations in support of new and ongoing clinical trials and other clinical research activities.
• Develop clinical quality management plans and materials to support the CIF research program.
• Review and assess existing clinical quality assurance efforts.
• Assess adherence to protocols, as well as relevant Air Force, DoD and FDA regulations and guidance.
• Complete routine audits of clinical study documentation and procedures to ensure adherence to above.
• Identify areas of deviation from protocols, ethical standards, regulations and or guidance, and recommend corrective actions.
• Document resolution of findings, analyze data and report non‐compliance to appropriate individuals.

Secondary Activities

• Develop and implement SOPs as or where necessary.
• Prepare research oversight and compliance documents and tools for assessment, as or where necessary.
• Serve as the liaison between study sponsors, investigators, departmental research personnel and other individuals assigned to the study.
• Independently develop training materials and conduct education of physician and nursing staff on specifics of the research protocol, study design, investigational therapeutic agents, procedures and/or techniques specific to the assigned study.
• Perform patient education regarding study participation, outlining protocol and time table of patient requirements.
• Coordinate the activities of research personnel to ensure quality patient care and adherence to research GCP principles.
• Focus on the care of research study patients with regard to each study's safety…