{bc}
Apply
oracle

Quality Auditor 1

Stanford University
Stanford, USA
Full-time
Mid
Hybrid
Discovered 2 weeks ago
GCP

Full Job Posting

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.

Apply for this job in 1 click

Skip the repetitive application forms

Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.

Sarah M.James T.Maya R.

Trusted by over 500,000 job seekers on Base Career

Start Free Today

More from this employer

More jobs at Stanford University

Cancer Clinical Research Coordinator Associate – GI (OnSite)

Stanford, USA

Discovered TodayFull-time

Cancer Clinical Research Coordinator Associate – GI (OnSite)

Stanford, USA

Discovered TodayFull-time

Senior Administrative Associate

Stanford, USA

Discovered 2 days agoFull-time

Senior Administrative Associate

Stanford, USA

Discovered 2 days agoFull-time

Administrative Associate 3

Stanford, USA

Discovered 2 days agoFull-time

Development Officer Specialist

Stanford, USA

Discovered 2 days agoFull-time

Research Data Analyst 1

Stanford, USA

Discovered 2 days agoFull-time

Laboratory Services Manager (24-Month Fixed-Term)

Stanford, USA

Discovered 2 days agoFull-time