Clinical Quality Assurance Auditor
About The Position
Innovo Research is seeking an experienced Clinical Quality Assurance Auditor to conduct Internal GCP audits across our multi-site clinical research network. This contract role performs structured, risk-based internal audits and retrospective file reviews to evaluate compliance with ICH-GCP, FDA regulations, and Innovo SOPs across: • Investigational drug trials • Medical device studies • Observational research The auditor will identify documentation gaps, assess workflow compliance, and support corrective actions to strengthen study quality and reduce regulatory risk. This role directly supports Innovo’s Quality Framework by providing independent audit coverage, addressing historical risks, and helping ensure consistent, compliant study execution across sites. This is a hands-on, execution-focused role ideal for an experienced auditor who can work independently and efficiently.
Requirements
- Bachelor’s degree in Life Sciences, Healthcare, or related field
- 5+ years clinical research experience
- 3+ years in QA auditing, CRA/monitoring, or clinical compliance oversight
- Strong knowledge of ICH-GCP and FDA regulations (21 CFR Parts 11, 50, 56, 312, 812)
- Experience reviewing source documentation, regulatory binders/eReg, and delegation logs
- Experience with electronic systems (CRIO/eSource preferred)
- Ability to work independently and manage multiple audits simultaneously
Nice To Haves
- Former CRA or CRO monitor
- Internal or sponsor auditing experience
- Multi-site research environments
- eConsent and eSource workflows
- CAPA remediation
- CRIO CTMS experience
- CQA/CCRA certification preferred
Responsibilities
- Plan and conduct internal audits of active and completed studies, including review of: Investigator oversight documentation
- Eligibility confirmation
- Informed consent and eConsent compliance
- Source documentation quality and contemporaneity
- Protocol deviations and documentation practices
- Safety reporting
- Delegation of Authority logs
- IP accountability and storage
- Regulatory binder/eReg completeness
- CRIO/eSource workflow documentation and data integrity
- Apply risk-based auditing appropriate to study type, including: Consent & HIPAA authorization documentation
- PHI handling and privacy protections
- Screening and recruitment logs
- Data integrity and minimal-risk study documentation standards
- Identify missing, inconsistent, or non-compliant documentation
- Document findings clearly and objectively
- Classify risks and trends
- Prepare concise internal audit reports
- Provide practical, actionable remediation recommendations
- Provide audit findings and trend insights to Quality & Compliance leadership
- Support documentation reconciliation and remediation efforts
- Contribute to consistent application of Innovo SOPs and quality expectations across sites
- Partner with CRCs, CRIO specialists, and Quality & Compliance teams
- Provide supportive, solutions-focused guidance to strengthen processes
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What This Job Offers
Career Level
Mid Level
