Job Description

Job Description

Job Description

Summary: 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, site risk mitigation, and acting as a quality professional and mentor. This individual will have both pharmaceutical clinical research experience and research auditing experience along with expert knowledge of Good Clinical Practice (GCP) and regulations governing clinical research. Management experience is also desirable along with excellent time management skills, the ability to multi-task, and build positive relationships.

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.

This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.

Requirements:

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

Continuing Education:

• GCP (Good Clinical Practice) – Must renew every 3 years
• IATA (dangerous goods handling) – Must renew every 2 years
• ALCOA-CCEA Certification
• Society of Clinical Research Associates (SOCRA) Certification – preferred.
• Association of Clinical Research Professionals (ACRP) Certification – preferred.

Competency Requirements:

• Strong organizational and time management skills.
• Excellent attention to detail and ability to maintain accurate records.
• Effective communication skills, both written and verbal.
• Ability to work independently and collaboratively in a team environment.
• Proactive problem-solving skills and adaptability in a dynamic setting.

Technical Competency Requirements:

• Understanding of ICH/GCP guidelines for human research
• Understanding of Code of Federal Regulations for Human Subject
• Computer Competency in Electronic Data Capture
• Understanding Phases I-IV drug development process.

Physical Requirements and/or environmental factors:

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift 20 pounds at a time.
• Subject/Patient Care
• Flexible schedule to support audit prep and inspection readiness travel.
• Travel is required as needed.

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