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 human microbiome outpatient research programs in the Cutaneous Microbiome and Inflammation Section, Dermatology Branch, NIAMS
• 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 assist in explaining the 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 biospecimen 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
• Assist in maintaining current regulatory documentation from numerous ongoing clinical research protocols
• Interface with NHGRI, 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
• Assist in the management of research subject files, copying and organizing research data
• Assist in 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
• Assist 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
• Assist in the identification of the responsible party for data input into ClinicalTrials.gov at study conclusion, as applicable
• Participate in efforts to ensure scientific quality and human subject’s protection
• Interact with auditing and monitoring agencies to facilitate the exchange of data
• Interface with the other protocol support personnel

• Bachelor’s degree in Nursing with current state nursing license
• Minimum of five (5) years of nursing experience with CPR certification
• Experience in a clinical research environment
• Knowledge of clinical research data collection and clinical data report preparation
• Working knowledge of ICH-GCPs
• Knowledge of the principles, theories, techniques and practices of general nursing
• Demonstrated expertise in data management
• Knowledge of Microsoft Office Suite (MS Word, Excel, Outlook) and other spreadsheet applications
• Strong communications skills, both oral and written
• Excellent analytical, organizational and time management skills

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