The Quality Assurance Specialist serves as a critical quality partner to Innovo’s clinical research sites. The role focuses on oversight of documentation quality, protocol adherence, PI oversight, data integrity, and readiness for internal and external audits. Specialists manage a portfolio of assigned sites and work proactively to identify risks, support compliance, and ensure continuous quality across all phases of study conduct.

Key Responsibilities

· Conduct independent quality reviews of regulatory files, source documentation, informed consent processes, and CRIO entries for protocol and GCP alignment.

· Assess documentation clarity, data accuracy, version control, and completeness across required study records.

· Evaluate PI oversight, including eligibility verification, safety review, visit approvals, and timely sign-offs.

· Identify operational risks, documentation gaps, trends, and patterns of noncompliance across assigned sites.

· Collaborate with site staff to resolve quality issues, provide clear feedback, and promote audit readiness.

· Identify root causes for issues and support development and tracking of Corrective and Preventive Action (CAPA) plans; verify effectiveness before closure.

· Prepare written quality summaries and communicate results to site teams and organizational leadership.

· Assist with pre-audit preparation, document sampling, and organization for internal, sponsor, CRO, or regulatory audits.

· Support post-audit follow-up, documentation requests, and CAPA requirements.

· Serve as the primary quality point of contact for assigned sites, supporting consistency and accuracy across all study documentation.

· Participate in routine Quality & Compliance meetings to review trends, discuss site status, and contribute findings to the annual Research Compliance Audit Plan and risk assessments.

Required

· Bachelor’s degree in a health-related, scientific, or regulatory field

· Minimum 2 years of clinical research experience (CRC, regulatory, QA, monitor, or auditor roles)

· Strong knowledge of ICH GCP and FDA regulations

· Familiarity and experience with FDA GCP guidelines and ALCOA/ALCOA+ data integrity principles

· Excellent attention to detail and organizational skills

· Ability to communicate professionally and effectively with site staff

· Experience with clinical research systems (e.g., CRIO, eReg, EDC)

Preferred

· Experience performing QA reviews or internal audits

· Familiarity with Looker, Notion, Salesforce, or research dashboards

· Experience working in multi-site or network-based clinical research environments

· Background in CAPA development or root-cause analysis

What We Offer

· Fully remote and flexible work environment

· Opportunity to support a growing quality program across a national research network

· A mission-driven culture centered on quality, integrity, and operational excellence

· Meaningful impact on research compliance and study quality