Summary

The Registered Nurse Quality Assurance Nurse Specialist is responsible for assisting in ensuring research studies are maintained and conducted in accordance with federal regulations - local polices - and Institutional Review Board (IRB) approvals - primarily focusing on patient safety - protocol integrity and accurate data collection.

Qualifications

Basic Requirements:

• English Language Proficiency
• In accordance with 38 U.S.C. 7403(f) - no person shall serve in direct patient care positions unless they are proficient in basic written and spoken English
• Graduate of a school of professional nursing approved by the appropriate accrediting agency and accredited by one of the following accrediting bodies at the time the program was completed by the applicant: The Accreditation Commission for Education in Nursing (ACEN) or The Commission on Collegiate Nursing Education (CCNE)
• OR Individuals attending a master's level bridge program in nursing who have completed coursework equivalent to a bachelor's level degree in Nursing may have opportunity to become registered as a nurse with a state licensing board prior to completion of the bridge program
• Upon achievement of a State license - the individual may be appointed on temporary basis and later converted to a permanent appointment upon successful completion and graduation from the bridge program
• (Reference VA Handbook 5005 - Appendix G6)
• OR In cases of graduates of foreign schools of professional nursing - possession of a current - full - active - and unrestricted registration will meet the requirement for graduation from an approved school of professional nursing to warrant an appointment as a Nurse who has completed an associated degree/entry level Nursing education program
• Credit for foreign nursing education higher that associate degree/entry level requires a formal degree equivalency validation from a recognized equivalency evaluation accepted by VA such as International Consultants of Delaware (ICD)
• Current - full - active - and unrestricted registration as a graduate professional nurse in a State - Territory or Commonwealth (i.e. - Puerto Rico) of the United States - or the District of Columbia
• Graduate Nurse Technician (GNT) Exception: Candidates who otherwise meet the basic education requirements - but do not possess the required licensure - may be appointed at the entry step of the grade and level applicable to the completed nursing education as a GNT on a 120-day temporary appointment while actively pursuing licensure (may be extended up to two years on a case-by-case-basis.) NOTE: Grandfathering Provision - All persons currently employed in VHA in 0610 series and performing the duties as described in the qualification standard on the effective date of the standard (1/29/2024) are considered to have met all qualification requirements for the grade held including positive education and licensure/certification
• Grade Determinations: The following Scope - Education and Dimension criteria must be met in determining the grade assignment of candidates - and if appropriate - the level within a grade
• The Dimension requirements (Practice - Veteran/Patient Driven Care - Leadership - Professional Development and Evidence-Based Practice/Research) are detailed for each grade and level within the online assessment: https://apply.usastaffing.gov/ViewQuestionnaire/13103128
• Grade/Level Scope Education Nurse I - Level I Delivers fundamental - knowledge-based care to assigned clients while developing technical competencies
• An Associate Degree (ADN) or Diploma in Nursing - with no additional professional nursing required
• Nurse I - Level II Demonstrates integration of biopsychosocial concepts - cognitive skills and technically competent practice in providing care to clients with basic or complex
• An ADN or Diploma in Nursing AND 1 year of specialized nursing experience equivalent to Nurse I - Level 1 ;OR a Bachelor of Science in Nursing (BSN) with no additional professional nursing experience required
• Nurse I - Level III Demonstrates proficiency in practice based on conscious and deliberate planning
• Self-directed in goal setting for managing complex client situations
• An ADN or Diploma in Nursing AND 2 years of professional nursing experience in which one year is equivalent to Nurse I - Level 2
• OR a BSN and 1 year of professional nursing experience equivalent to the Nurse I - Level 2
• OR a Master's degree in nursing (MSN) and no additional professional nursing experience
• OR a Master's degree in a *related field with a BSN and no additional professional nursing experience
• Nurse II Demonstrates leadership in delivering and improving holistic care through collaborative strategies with others
• A BSN with 2 years of professional nursing equivalent to Nurse I - Level 3
• OR an MSN with one year of specialized nursing experience equivalent to Nurse I - Level 3
• OR a Master's degree in a *related field with a BSN and one year of specialized nursing experience equivalent to Nurse I - Level 3
• OR a Doctoral degree in Nursing with no professional nursing experience
• OR a Doctoral degree in a *related field with a BSN with no additional professional nursing experience
• Nurse III Executes position responsibilities that demonstrate leadership - experience and creative approaches to management of complex client care beyond the immediate practice setting
• MSN and 2 years of specialized nursing experience - one of which is equivalent to Nurse II and meets all dimension requirements for Nurse III
• OR a Master's degree in *related field with BSN and two years of specialized nursing experience - one of which is equivalent to Nurse II and meets all dimension requirements for Nurse III
• OR a Doctoral degree in Nursing with and one year of specialized nursing experience equivalent to Nurse II and meets all dimension requirements for Nurse III
• OR a Doctoral degree in a *related field with a BSN and one year of specialized nursing experience equivalent to Nurse II and meets all dimension requirements for Nurse III
• *Note: Foreign education programs/degrees are not creditable as related degrees
• Preferred Experience: Experience extracting and preparing medical record data Experience performing medical record/chart reviews to verify accurate data collection - reporting of adverse events - and protocol deviations
• Experience assisting with the development and review of informed consent documents - including identifying and addressing ethical considerations in a research context
• Experience assisting developing source documents - training materials - or case report forms (CRFs) for use at clinical research sites
• Reference: For more information on this qualification standard - please visit https://www.va.gov/ohrm/QualificationStandards/
• Physical Requirements: This position requires visual acuity - keen hearing - clear distinctive speech - and manual dexterity
• This position requires potentially long periods of continued walking - standing - stooping - sitting - bending - pulling - pushing and reaching over head
• Transferring patients and objects may be required.

Duties

• Registered Nurse Quality Assurance Nurse Specialist provides nursing and clinical expertise to the research process in the planning and conducting of multi-center - controlled clinical trials for the Cooperative Studies Program Coordinating Center (CSPCC)
• Demonstrates specialized experience and leadership that is characterized by responsibility and accountability for an integrated program that crosses services and/or discipline lines and influences the organizational mission
• Influences process improvement initiatives by collaborating with members of the interdisciplinary team
• Assists in evaluating data integrity and ensuring trials are compliant with regulations and policies
• Reviews medical records and collects data values in accordance with the scope of the project
• Executes position responsibilities that demonstrate leadership - experience - and creative approaches to management of research processes
• Responsibilities include - but are not limited - to the following: Assists in monitoring site compliance with research protocols by reviewing regulatory requirements to confirm implementation of appropriate methods - practices - and procedures for research activities
• Educates study teams as it relates to patient care during the participation in a research study and providing guidance on good clinical practice guidelines as it relates to administering investigational drugs or treatments
• Provides feedback to study team and investigators on issues affecting the quality of the research endeavor - assists less-experienced staff in learning the specifics of studies or protocols
• Assists in the development of informed consents
• Anticipates and identifies ethical conflicts and plans with the multidisciplinary research team to address them
• Supports the regulatory staff in the maintenance of regulatory documents in accordance with Standard Operating Procedures (SOPs) and applicable regulations
• Develops source materials for use at clinical sites and assists with training of site personnel on protocol and study procedures
• Assists in case report form (CRF) development and ensures CRFs capture necessary clinical data points as outlined in the protocol
• Reviews informed consents for completion and compliance
• Develops and drives quality improvement for study recruitment protocols and evaluates the success of recruitment efforts for diversity and inclusion where possible
• Provides support in developing integrated monitoring plans and monitoring study metrics
• Reviews medical charts to confirm accurate reporting of safety events and protocol deviations
• Performs retrospective medical chart reviews and collects data points on CRFs as detailed in study protocols
• Extracts relevant medical records for clinical outcome adjudication committees and assists adjudication committee members in resolving discrepancies as needed
• Develops methods to collect participant satisfaction and make recommendations as needed for improvement based on data collected
• VA offers a comprehensive total rewards package: VA Nurse Total Rewards Pay: Competitive salary - regular salary increases - potential for performance awards Paid Time Off: 50 days of paid time off per year (26 days of annual leave - 13 days of sick leave - 11 paid Federal holidays per year) Retirement: Traditional federal pension (5 years vesting) and federal 401K with up to 5% in contributions by VA Insurance: Federal health/vision/dental/term life/long-term care (many federal insurance programs can be carried into retirement) Licensure: 1 full and unrestricted license from any US State or territory Work Schedule: Monday thru Friday
• 8am to 4:30pm Telework: Available - Ad-hoc pending supervisory approval and facility instruction Virtual: This is not a virtual position
• Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized