Research Nurse Jobs

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

Responsibilities:

• Work with staff on clinical research protocol development
• Interface with the other protocol support personnel
• Support the needs of data integrity and retrieval
• Assist in updates for clinical staff on patient care, protocol process and progress, human rights protection, ICH Good Clinical Practices and quality assurance education
• Assist investigators and medical writers on the production/revision of clinical research protocols
• Provide clinical care and direct nursing support for human microbiome outpatient research programs in the Cutaneous Microbiome and Inflammation Section, Dermatology Branch, NIAMS
• Work with medical staff on skilled procedures
• Assist in the management of research subject files, copying and organizing research data
• Develop patient rapport and assist in explaining the protocol and tests/procedures to the patients
• Collaborate with PIs to interpret research data for protocol team
• 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
• Document patient care via established guidelines
• Consult with health care professionals regarding medical, psychological, and/or social patient needs
• Assist in maintaining current regulatory documentation from numerous ongoing clinical research protocols
• Follow subjects between visits; collaborate with community physicians to further the continuity of care and protect the integrity of the clinical research protocol/data
• Visit off-site collaborative centers
• Serve as liaison between clinical and laboratory sites, and with Principal Investigators (PIs)
• Assist in the identification of the responsible party for data input into ClinicalTrials.gov at study conclusion, as applicable
• Oversee ongoing protocol operations to ensure study compliance; troubleshoot possible protocol violations
• Order protocol-mandated tests, labs, and procedures
• Participate in efforts to ensure scientific quality and human subject’s protection
• 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
• Work with staff to create case report forms
• Assess, plan and follow up with disease noted attributes
• Participate in quality improvement and quality assurance initiatives involving database and data system development efforts
• 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
• Work with staff to develop procedure manuals for clinical research protocols
• Recruit and enroll research subjects
• Interact with auditing and monitoring agencies to facilitate the exchange of data

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

Cape Fox Corporation, its subsidiaries and affiliates provide equal employment opportunities to all persons and prohibit employment decisions on the basis of race, religion, color, creed, national origin, sex, age, disability, political affiliation, protected veteran status, or sexual orientation. Cape Fox Corporation, its subsidiaries and affiliates offer preference to Cape Fox Corporation shareholders, descendants and other Native Americans pursuant to Public Law 100-241.