layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Quality Auditor 1 at Stanford University, Stanford, CA

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.

Quality Auditor 1

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