Registered Nurse - Quality Assurance Nurse Specialist

Veterans Health Administration•Perry Point, MD
•Onsite

About The Position

The Registered Nurse Quality Assurance Nurse Specialist provides nursing and clinical expertise for planning and conducting multicenter, controlled clinical trials for the Cooperative Studies Program Coordinating Center (CSPCC). The role helps ensure research studies are conducted and maintained in accordance with federal regulations, local policies, and Institutional Review Board (IRB) approvals, with a focus on patient safety, protocol integrity, and accurate data collection. The position demonstrates specialized experience and leadership in managing research processes across services or disciplines and contributes to the organizational mission and process improvement initiatives through interdisciplinary collaboration. The specialist supports study teams and investigators by assessing data integrity and regulatory compliance, reviewing medical records, collecting data, and advising on patient care and good clinical practice. The role also supports regulatory documentation, informed consent development and review, site materials and training, case report form development, recruitment quality improvement, monitoring plans and metrics, safety-event and protocol-deviation review, clinical outcome adjudication, and participant satisfaction assessment. The position is scheduled Monday through Friday, 8:00 a.m. to 4:30 p.m. Ad hoc telework may be available with supervisory approval and facility instruction; this is not a virtual position. Relocation and recruitment incentives and permanent change of station are not authorized.

Requirements

  • Graduate from an approved school of professional nursing accredited by ACEN or CCNE, or meet the stated applicable education pathway for nursing graduates, including qualifying foreign nursing education.
  • Hold current, full, active, and unrestricted RN registration in a U.S. state, territory, commonwealth, or the District of Columbia; the stated Graduate Nurse Technician exception may apply to eligible candidates pursuing licensure.
  • Demonstrate basic written and spoken English proficiency.
  • Meet the education and professional nursing experience requirements for the applicable VA Nurse grade and level.
  • Meet the position's physical requirements, including visual acuity, keen hearing, clear distinctive speech, manual dexterity, and capacity for potentially prolonged walking, standing, stooping, sitting, bending, pulling, pushing, and overhead reaching; transferring patients and objects may be required.
  • Meet VA employment conditions, including U.S. citizenship unless an applicable exception allows appointment of a non-citizen, required background/security investigation, pre-employment physical evaluation, and seasonal influenza vaccination program participation.
  • Applicants tentatively selected for a testing-designated position must undergo urinalysis for illegal drug use before appointment.

Nice To Haves

  • Experience extracting and preparing medical-record data.
  • Experience performing medical-record or chart reviews to verify accurate data collection and reporting of adverse events and protocol deviations.
  • Experience assisting with development and review of informed consent documents, including identifying and addressing ethical considerations in a research context.
  • Experience assisting with development of source documents, training materials, or case report forms (CRFs) for clinical research sites.

Responsibilities

  • Assist in monitoring research-site compliance with protocols by reviewing regulatory requirements and confirming appropriate research methods, practices, and procedures.
  • Educate study teams about patient care during research participation and provide guidance on good clinical practice for administering investigational drugs or treatments.
  • Provide feedback to study teams and investigators about issues affecting research quality and help less-experienced staff learn study and protocol requirements.
  • Assist with developing informed consent documents, identify potential ethical conflicts, and work with the multidisciplinary research team to address them.
  • Support regulatory staff in maintaining regulatory documents in accordance with standard operating procedures and applicable regulations.
  • Develop source materials for clinical sites and assist with training site personnel on protocols and study procedures.
  • Assist in developing case report forms (CRFs) and ensure they capture clinical data points required by study protocols.
  • Review informed consents for completeness and compliance.
  • Develop and drive quality improvement for study recruitment protocols and evaluate recruitment success for diversity and inclusion where possible.
  • Support development of integrated monitoring plans and monitoring of study metrics.
  • Review medical charts to verify accurate reporting of safety events and protocol deviations.
  • Conduct retrospective medical-chart reviews and collect protocol-specified data points on CRFs.
  • Extract relevant medical records for clinical outcome adjudication committees and help committee members resolve discrepancies as needed.
  • Develop methods to collect participant satisfaction data and recommend improvements based on the collected data.
  • Assist with evaluating data integrity and ensuring trials comply with regulations and policies.
  • Review medical records and collect data values within the scope of the project.

Benefits

  • Competitive salary, regular salary increases, and potential performance awards.
  • 50 days of paid time off per year: 26 days of annual leave, 13 days of sick leave, and 11 paid federal holidays.
  • Traditional federal pension with five-year vesting and federal 401(k), with up to 5% in contributions by VA.
  • Federal health, vision, dental, term life, and long-term care insurance; many federal insurance programs can be carried into retirement.
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