Job Description

Job Title: Clinical QA Specialist (Remote)

Location: Houston, TX

Duration: 6 months (with potential extensions)

Responsibilities:

• Lead efforts to clear a backlog of CAPAs related to clinical trial operations and conduct for a Class 3 implantable sleep apnea device study.
• Ensure all clinical trial data is audit-ready, addressing gaps identified during the internal Mock FDA audit.
• Author and resolve CAPAs quickly and efficiently to meet the deadlines for FDA audit preparation.
• Work closely with the clinical operations and quality teams to ensure regulatory compliance.
• Perform root cause analysis and implement corrective and preventive actions to mitigate risks.
• Prepare and present documentation for FDA audit readiness.
• Collaborate cross-functionally to ensure proper documentation, investigation, and closure of CAPAs.

Requirements:

• 5+ years of experience working with CAPAs related to Trial Operations and Trial Conduct .
• Class 3 implantable medical device experience is mandatory.
• Phase III IDE study experience with Class 3 medical devices is required.
• Hands-on experience in authoring and resolving CAPAs quickly and efficiently.
• Strong background in clinical medical quality assurance , specifically in clinical trials .
• Experience with sleep apnea implantable devices is highly desired but not required.
• Must be able to work independently, demonstrating a hands-on approach to problem-solving.
• Ability to start immediately and work remotely to meet the client's urgent needs

Preferred Qualifications:

• Prior experience with Class 3 IDE studies in sleep apnea or related fields.
• Familiarity with FDA audit processes and standards in clinical operations for medical devices.

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