Health Care | Bethesda, MD | Full Time
Research Nurse- Bethesda,MD
CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. The contractor must have:
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.
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.
TASKS/SERVICES. The contractor shall:
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 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.
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.