- 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 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
- Master's degree in Nursing with current state licensure; two (2) years of specialized experience plus a Bachelor's degree is equivalent to a Master's degree
- 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
- Ability to 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.
- Ability to participate in efforts to ensure scientific quality and human subjects' protection.
- Ability to oversee ongoing protocol operations to ensure study compliance; troubleshoot possible protocol violations.
- 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
- Ability to recruit and enroll research subjects.
- Ability to interface with multiple ICs, or other relevant Institutional Review Board (IRB); coordinate filing of UPs, AEs, amendments, continuing review applications, annual reports, protocol inactivation and other regulatory documents.
- Ability to provide clinical care and direct nursing support for human microbiome research programs in the Cutaneous Microbiome and Inflammation Section, Dermatology Branch, NIAMS
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Research Nurse - Rockville, United States - Cape Fox Corporation
Description
Job Title
Research Nurse
Job Description
Concentric Methods is seeking a Research Nurse to join our team in Bethesda, MD in support of the NIH.
Responsibilities:
0 - 10%
Salary Grade
Job Requirements
Category
Healthcare
Location
NIH - Bethesda, MD - Rockville, MD 20892 US (Primary)
Education
Bachelor's Degree
