Quality Assurance

Summary: The Quality Assurance Specialist works under the supervision of the Senior Vice President of Quality Control (QC) and in accordance with industry regulations, company policies and Standard Operating Procedures to support the site network by driving a culture of quality, compliance, and inspection readiness. The Quality Assurance Specialist will be responsible for conducting routine onsite audits of network sites, identifying site-level deviations, improving workflows, and ensuring the safety of participants and the integrity of data across multiple clinical trials. 

Duties and Responsibilities:

• Conduct internal audits of clinical study records and site processes to ensure compliance with internal SOPs, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory (FDA) requirements

• Review study documents (informed consent forms, source documents, regulatory files, pharmacy and laboratory records) to ensure accuracy, completeness, and protocol adherence


• Interview and evaluate site staff 


• Assess site equipment and capabilities

• Generate detailed reports and summaries of site visits


• Identify compliance issues and make recommendations for areas of improvement


• Collaborate with multiple departments to improve processes, maintain quality standards and prepare clinical research sites for audits and/or regulatory inspections

• Minimum of 3 years in clinical research and/or


• Bachelor’s degree in a scientific, nursing, or healthcare field

• Strong understanding of pharmaceutical clinical trial conduct


• Familiar with clinical trial protocol elements


• Thorough knowledge of FDA, GCP, ICH guidelines, and IRB regulations


• Auditing or monitoring experience preferred 

• Ability to interact with site representatives


• High-level of integrity

• Deep understanding of clinical trial processes, industry regulations, and market dynamics


• Excellent analytical and strategic planning abilities


• Adaptable to evolving market demands and regulatory landscapes


• Strong organizational and project management skills


• Ability to work independently while managing multiple priorities in a fast-paced environment

• Effective written and verbal language skills


• Ability to read, analyze, and interpret business and technical materials and effectively communicate through written reports, correspondence, and presentations to diverse audiences


• Proficiency in Microsoft Office Suite, internet browsers, and cloud-based enterprise systems to support operational and analytical tasks


• Ability to define problems, analyze data, interpret complex instructions, and draw sound conclusions while managing multiple variables


• Ability to perform calculations such as percentages and metric or standard conversions and apply basic algebra to support business analysis


• High attention to detail and analytical skills

• Deep understanding of clinical trial execution and regulatory standards


• Culture, values, and organizational alignment

Certificates and Licenses: 

• Valid Driver’s License and personal auto insurance.


• GCP Certification. 

FLSA Classification: This is an exempt position.

 Work Environment and Physical Demands: The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work may be performed in an office environment.


• Occasional domestic and/or international travel may be required (30-40%).