Job Description

**Seeking a Quality Insurance Manager for a well known Clinical Research Site in Dallas, Texas**

Summary:

We are looking to add a full time Quality Assurance Manager to our growing team. This role can be based out of Dallas, TX or Montclair, CA and will require up to 25% travel. The ideal candidate must have a minimum of 3-5 years of site based Clinical Research experience in phase I-III clinical trials.

The Quality Assurance Manager will be responsible for ensuring research site quality across the research site network. This will include performing on-site and remote audits, writing quality reports and Corrective and Preventative Actions (CAPAs), tracking and trending data, and site risk mitigation.

Responsibilities

• Completes clinical investigator site audits to assess adherence to the Study Protocol and associated documents, GCP, standard operating procedures (SOPs) and applicable regulations.
• Prepares internal trend analysis of audit observations; addresses audit risks through Corrective and Preventative Actions and identifies and communicates to the VP of Quality Assurance any compliance risks.
• Works with research sites to ensure that the Research Site Visits, and Vendor Audits are scheduled and approved by the VP of Quality Assurance.
• This position is accountable, under the leadership of the VP of Quality Assurance, to develop and lead inspection readiness activities for Clinical Research sites.
• Develops, implements, and monitors processes to ensure exceptional quality at clinical research sites.
• Develops and implements relevant QA SOPs, as needed.
• Occasional travel to Company sites and/or Company meetings.

Requirements:

• Bachelor’s degree, a health science major is preferred.
• 3+ years of pharmaceutical clinical research experience.
• 3+ years of auditing experience.

Duties and Responsibilities: The Quality Assurance Manager:

• Completes clinical investigator site audits to assess adherence to the Study Protocol and associated documents, GCP, standard operating procedures (SOPs) and applicable regulations.
• Prepares internal trend analysis of audit observations; addresses audit risks through Corrective and Preventative Actions and identifies and communicates to the VP of Quality Assurance any compliance risks.
• Works with research sites to ensure that the Research Site Visits, and Vendor Audits are scheduled and approved by the VP of Quality Assurance.
• Maintains compliance with federal, state, and local laws as well as regulations governing clinical research to ensure compliance.
• This position is accountable, under the leadership of the VP of Quality Assurance, to develop and lead inspection readiness activities for Clinical Research sites.
• Develops, implements, and monitors processes to ensure exceptional quality at clinical research sites.
• Represents Quality Assurance (QA) for clinical research compliance advice and guidance as needed.
• Develops and implements relevant QA SOPs, as needed.
• Effectively communicates quality issues to the management team in a timely manner.
• Performs other duties as assigned.
• Occasional travel to Company sites and/or Company meetings.

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