Quality Assurance Manager

Location: Remote US-Based

Travel Requirements: Up to 25%

Overview

American Clinical Research Services is seeking a well-qualified, highly motivated Quality Assurance Manager to join the Quality Assurance team. 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. This role will report to the Director of Quality.

Essential Functions

• 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 Director of Quality any compliance risks
• Works with research sites to ensure that the Research Site Visits, and Vendor Audits are scheduled and approved by the Director of Quality
• 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 Director of Quality, 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
  
  

Skills And Qualifications

• Bachelor’s degree, a health science major is preferred
• 3+ years of pharmaceutical clinical research and 3+ years of auditing experience
• Knowledge of ICH-GCP and FDA Regulations
• Medical terminology expertise
• Attention to detail, Focused and Self-driven, Problem-solver
• Ability to travel on average 1-2 times a month
• Flexible schedule to support audit prep and inspection readiness travel
• Strong supervisory and leadership skills
  
  

Preferred Qualifications

• Proficiency in Microsoft Office applications (Outlook, Word, PowerPoint, and Excel)
• Professional written and spoken communication skills
  
  

CSSi, An ACRS Company

Founded in 2005, CSSi is a patient recruitment company offering end-to-end services across the globe. As an industry leader, CSSi delivers strategic patient recruitment, enrollment, and retention solutions to Pharmaceutical & Biotech sponsors, CROs, and clinical research sites.

With nearly 20 years of patient recruitment experience in over 50 countries, CSSi has deployed strategic recruitment campaigns in more than 30 therapeutic areas. Our in-house team offers robust experience in all aspects of recruitment and retention and leverages a unique and differentiated site engagement model. Ultimately, CSSi is focused on helping sponsors and CROs drive clinical trial enrollment by implementing customized enrollment solutions that meet site’s unique recruitment needs. CSSi was acquired by ACRS in 2023.

About ACRS

American Clinical Research Services (ACRS) Holdings was founded to improve the quality of life for millions of Americans through scientific research. Given the challenges in patient recruiting and the increased complexity around clinical trials, ACRS is focused on the opportunity to achieve efficiencies in a highly fragmented sector.

All employees must be authorized to work in the United States. ACRS provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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