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Clinical Research Nurse
2 months ago
NIH Hierarchy:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Roles/Responsibilities:
- Coordinate patient schedules, data collection, and nursing care.
- Assist physicians with skilled procedures.
- Coordinate with other research nurses, providers, patient care coordinators, and other NIH staff to conduct study.
- Order protocol mandated tests, labs, and procedures.
- Alert physician of adverse events, abnormal outcomes, or problematic trends.
- Enter protocol data in database management system.
- Follow patients between visits collaborating with community physicians.
- Assist in the creation of case report forms. Complete subject case report forms.
- Oversee ongoing protocol operations to ensure study compliance and troubleshoot possible protocol violations/deviations.
- Interface with the Institutional Review Board (IRB), protocol navigators, study monitors, data managers, and protocol managers to coordinate and ensure proper and timely filing of Adverse Events (i.e. UP's, SAE's, SUSAR's), assist with the writing and submission of modifications, amendments, annual reports, and other regulatory documents.
- Coordinate changes to the protocol or consent documents. Essential duties also include checking patient eligibility for clinical trials, obtaining informed consent from eligible subjects.
- Conduct updates for clinical staff on patient care, protocol process and progress, human subject’s protection, and ICH Good Clinical Practices.
- Remain compliant with required training, HHS regulations, and NIH policies.
- Assist PI in interpreting research data for the protocol team.
Minimum Requirements:
- Bachelor’s degree in Nursing with current state nursing licensure.
- Professional knowledge of the principles, theories, techniques, and practices of nursing with immunologic illnesses.
- Minimum of 3 years’ experience in a clinical research environment.
- Experience with IND clinical trials preferred.
- Knowledge of clinical research data collection and clinical data report preparation.
- Knowledge of ICH GCPs.
- Prior experience in adult and pediatric clinical trials management preferred.
- Must be CPR certified or certifiable.
- Knowledge of Microsoft Office Suite (MS Word, Excel, Outlook) and spreadsheet applications.
- Strong communications skills, both oral and written.
- Excellent analytical, organizational and time management skills.
