The posting
Job Description
Clinical Research Quality (CRQ), a unit within Spectrum and the Senior Associate Dean of Research Office at Stanford University School of Medicine, is seeking a Quality Assurance Auditor 1 to conduct internal audits of clinical research studies. The auditor will evaluate compliance with federal regulations, Good Clinical Practice (GCP), IRB approvals, institutional policies, and study protocols. The incumbent will collaborate with investigators and research teams to identify opportunities for quality improvement, prepare standardized audit reports, support corrective and preventive action (CAPA) activities, and provide education to promote regulatory compliance.
The Quality Auditor will also participate in sponsor audits and regulatory inspections, assist research teams in preparing for external audits, and contribute to the development and maintenance of quality systems and audit documentation. The role works closely with investigators, study teams, and institutional partners to strengthen research quality and advance continuous improvement across the clinical research enterprise.
CRQ supports the School of Medicine’s commitment to high-quality, compliant clinical research. As part of Spectrum—an interdisciplinary center that advances clinical and translational research—CRQ provides infrastructure, education, consultation, and innovative programs that accelerate the translation of scientific discoveries into improved human health.
This position is based in Stanford’s Research Park and has the option of a telecommuting/hybrid schedule subject to operational needs.
In this role you will:
- Evaluate clinical research studies of varying complexity, therapeutic areas, and phases, including drug, cell therapy, and medical device studies. Assess compliance in areas such as informed consent, participant eligibility, safety reporting, investigational product accountability, data integrity, and applicable FDA/GCP requirements.
- Independently coordinate assigned audits from initiation through closure, including scheduling, developing sampling strategies, categorizing findings based on compliance risk, presenting findings to study teams, and preparing audit reports. Consult with senior quality staff as appropriate for more complex audits.
- Review sponsor audit reports and FDA Form 483 responses, assess the adequacy of proposed corrective actions, and conduct effectiveness checks to verify resolution of identified deficiencies.
- Conduct mock audits, provide inspection-readiness tools and training materials, offer guidance to research teams during external inspections, and prepare inspection updates and reports for leadership.
- Provide targeted education on Good Documentation Practices, Root Cause Analysis, CAPA Planning and Implementation, and Audit Readiness. Collaborate with institutional partners, including the IRB, Cancer Clinical Trials Office, Stanford Center for Clinical Research, University Internal Audit and Privacy, and School of Medicine departments and programs.
DESIRED QUALIFICATIONS:
- Experience conducting clinical research quality assurance or regulatory compliance audits within academia or healthcare
- Knowledge of FDA regulations, ICH Good Clinical Practice (GCP), HIPAA, and human subject protection requirements
- Experience auditing investigator-initiated and industry-sponsored clinical research studies
- Experience supporting sponsor audits, FDA inspections, or other regulatory inspections
- Strong organizational skills with the ability to manage multiple concurrent audits and meet established deadlines
- Professional certification such as ACRP, SOCRA, or Certified Quality Auditor (CQA)
Responsibilities
Core Duties:
- Audit clinical research protocols to identify potential issues of adherence and regulatory compliance.
- Review protocol documents to create audit plan, select subject case files to be audited, and review source documentation (which may include medical records as allowed by HIPAA regulations).
- Collect data and backup documents to determine if the research team is in compliance with protocol and regulatory requirements.
- Identify quality issues/non-conformance, and work with study teams to complete Corrective Actions and Preventive Actions (CAPAs).
- Contribute to maintaining an organizational and operational structure for tracking a large amount of information (e.g., SmartSheet or REDCap).
- Provide guidance to Sponsor-Principal Investigators to help ensure that the additional responsibilities of holding an Investigational New Drug (IND) or Investigational Device Exempt (IDE) are met.
- Working as a member of an audit team may contribute to training research teams in self-auditing techniques. Preparing for FDA audits, assisting with external audit preparation, and presenting at educational meetings.
- Participates in Sponsor, Regulatory Agency audits and inspection.
- May participate in more complex audit(s) or an external audit as part of team, lead by and under the direction of senior team members.
Minimum Education:
Bachelor's degree
Minimum Experience:
4 years of related experience with 2 years in clinical research in industry or academia managing complex compliance issues, or an equivalent combination of education and relevant work experience.
Knowledge, Skills and Abilities:
- Strong analytical, interpersonal, written, and oral communication skills.
- Proven auditing ability, skilled in reporting on internal and external quality systems
- Demonstrated knowledge of clinical research regulations including the principles of Good Clinical Practice
- Knowledge/understanding of federal, state, and local regulations regarding the conduct of clinical trials, the informed consent process, and the protection of human research subjects.
- Strong technical skills and experience with quality systems, methods and concepts, SOP.
- Strong team-oriented, interpersonal skills and collaborative work style.
- Demonstrated ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
- Excellent organizational skills and superb attention to detail; strong communication and interpersonal skills as information will be communicated in electronic, written, and verbal communications to principal investigators, medical and research personnel.
Certificates and Licenses Required
Society of Clinical Research Associate or Association of Clinical Research Professionals certification is preferred.
