Quality Operations Lead (Remote Contract)

Evolution Research Group; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Evolution Research Group seeks a Quality Operations Manager (Contract) to support the VP Quality Operations and implement quality initiatives across the CRO quality program. You will collaborate with Regulatory, Monitoring, IT/Clinical Systems, Data Management, and Biostatistics teams on study document review and CAPA management.

Responsibilities include conducting internal eTMF and system audits, preparing audit materials, and training staff to ensure ongoing compliance with FDA and sponsor

Qualifications

• Bachelor's degree in a scientific/healthcare field with 5–7 years of related experience; knowledge of FDA regulatory requirements.
• GCP-focused clinical QA auditing experience preferred; other QA experience in clinical sites, CRO, or sponsor acceptable.
• Strong writing, presentation, and communication skills; ability to manage multiple tasks and work in a team.

Responsibilities

• Review study documents and provide feedback to ensure compliance with protocol, regulatory requirements, SOPs, and sponsor standards.
• Support audits and sponsor interactions, including preparation, interviews, and document retrieval; participate in audit findings and responses.
• Prepare internal eTMF and system audits; assist with training and maintaining the Training Matrix and files.

Skills

Communication skills

Education

Bachelor's degree in science/healthcare

Tools

Microsoft Office

Job description

Evolution Research Group seeks a Quality Operations Manager (Contract) to support the VP Quality Operations and implement quality initiatives across the CRO quality program. You will collaborate with Regulatory, Monitoring, IT/Clinical Systems, Data Management, and Biostatistics teams on study document review and CAPA management.

Responsibilities include conducting internal eTMF and system audits, preparing audit materials, and training staff to ensure ongoing compliance with FDA and sponsor