Concentric Methods is seeking a Research Nurse to join our team in Bethesda, MD in support of the NIH.

Responsibilities:

• Provide clinical care and direct nursing support for the Dermatology Branch outpatient research programs
• Document patient care via established guidelines
• Assess, plan and follow up with disease noted attributes
• Coordinate various activities (research subject schedules, data and biospecimen collection, and nursing care) to ensure proper and timely filing of standard clinical/regulatory documentation, serious adverse events, amendments, annual reports and other regulatory documents
• Recruit and enroll research subjects
• Develop patient rapport and work with staff on explaining protocol and tests/procedures to the patients
• Consult with health care professionals regarding medical, psychological and/or social patient needs
• Work with medical staff on skilled procedures
• Order protocol-mandated tests, labs and procedures
• Distribute biodspecimen kits; coordinate biospecimens for testing and diagnostic and research purposes (including referring MDs, NIH labs and repositories) and log biospecimen samples in appropriate database
• Follow subjects between visits; collaborate with community physicians to further the continuity of care and protect the integrity of the clinical research protocol/data
• Serve as liaison between clinical and laboratory sites, and with Principal Investigators (PIs)
• Work with staff on clinical research protocol development
• Work with staff to develop procedure manuals for clinical research protocols
• Work with staff to create case report forms
• Visit off-site collaborative centers
• Oversee ongoing protocol operations to ensure study compliance; troubleshoot possible protocol violations
• Work with staff on maintaining current regulatory documentation form numerous ongoing clinical research protocols
• Interface with NIAMS/NIDDK or other relevant Institutional Review Board (IRB); coordinate filing of Ups, AEs, amendments, continuing review applications, annual reports, protocol inactivation and other regulatory documents
• Work with staff on the management of research subject files; copy and organize research data
• Work on updates for clinical staff on patient care, protocol process and progress, human rights protection, ICH Good Clinical Practices and quality assurance education
• Collaborate with PIs to interpret research data for protocol team
• Work with investigators and medical writers on the production/revision of clinical research protocols
• Support the needs of data integrity and retrieval
• Participate in quality improvement and quality assurance initiatives involving database and data system development efforts
• Work with staff to identify the responsible party for data input into ClinicalTrials.gov at study conclusion, as applicable
• Participate in efforts to ensure scientific quality and human subjects' protection
• Interact with auditing and monitoring agencies to facilitate the exchange of data
• Interface with other protocol support personnel