Clinical Research Quality Assurance (QA) Analyst

Inova Office of Research - Quality Assurance team is seeking a dedicated Clinical Research Quality Assurance Analyst to join the team. This role will be full-time Monday - Friday, Hybrid Day shift.

Inova is consistently ranked as a national healthcare leader in safety, quality and patient experience. We are also proud to be consistently recognized as a top employer in both the D.C. metro area and the nation.

Featured Benefits:

• Committed to Team Member Health: offering medical, dental and vision coverage, and a robust team member wellness program.
• Retirement: Inova matches the first 5% of eligible contributions - starting on your first day.
• Tuition and Student Loan Assistance: offering up to $5,250 per year in education assistance and up to $10,000 for student loans.
• Mental Health Support: offering all Inova team members, their spouses/partners, and their children 25 mental health coaching or therapy sessions, per person, per year, at no cost.
• Work/Life Balance: offering paid time off, paid parental leave, flexible work schedules, and remote and hybrid career opportunities.

Clinical Research Quality Assurance Analyst Job Responsibilities:

• Demonstrates in-depth knowledge of GCP, GLP, and applicable federal regulations governing clinical research.
• Assists in managing internal auditing functions and supports the development of training programs aligned with organizational needs and international GCP/GLP standards.
• Serves as an internal resource to principal investigators and study teams, providing expert guidance in developing and implementing Corrective and Preventive Action (CAPA) plans.
• Collaborates with cross-functional teams to build and enhance comprehensive clinical research regulatory and support infrastructure.
• Engages in ongoing professional development by attending webinars, conferences, and in-service trainings to stay current with evolving regulations and best practices in clinical research.
• Ensures quality and ethical integrity in the identification, recruitment, screening, and retention of research participants, with consideration for inclusion of diverse populations.
• Performs comprehensive monitoring activities, including verification of informed consent, source data review, regulatory binder assessment, and evaluation of PI and CRC responsibilities, to ensure compliance with IRB-approved protocols, GCP, and institutional SOPs.
• Conducts internal, sponsor, and regulatory-style audits of clinical studies; differentiates between routine and for-cause audits, identifies common triggers (e.g., deviations, safety issues, noncompliance), and prepares detailed audit reports with recommended corrective actions.
• Serves as an internal resource to principal investigators and study team while providing guidance with CAPA creation.

Minimum Qualifications:

• Education: Bachelor degree in Science/healthcare or research related field.
• Experience: Two (2) years' experience in clinical research field or research quality assurance.

Preferred Qualifications:

• Experience working with FDA-regulated IND/IDE clinical trials.
• In-depth understanding of ICH-GCP guidelines and their practical application.
• Hands-on experience developing Corrective and Preventive Action (CAPA) plans.
• Proven involvement in SOP authorship, review, or revision.
• Direct participation in conducting both on-site and remote monitoring visits to assess site compliance with protocol, GCP, and regulatory requirements.
• ACRP or SOCRA certified.

#LI-MF1