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.
- 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)
- 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
- 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
About the company
Company website•Medical Practices
Innovo Research is a provider-sponsored, provider-led network of high-performing Accountable Care Organizations (ACOs) that utilize clinical research as part of their population health strategy. Our integrated approach supports both the triple aim aspirations of our partner ACOs as well as their research interests. We also add value to the pharma industry by assisting with the pragmatic design of future trials and observational study capabilities once their therapeutic is in the market. In addition, we can follow cohorts of patients throughout the various stages of development and deployment of the therapeutic. The results are better outcomes for patients, lower cost for the healthcare industry, higher patient engagement, and a diversified revenue source for our partner ACOs.
Our Mission
At Innovo Research, our mission is to promote clinical research as a patient care option by demonstrating its value to all stakeholders, while dramatically reducing the time it takes to develop new therapeutics.
To provide onsite management for each study, Innovo Research has partnered with IQVIA, a leader in healthcare intelligence. IQVIA ensures each piece of data is collected consistently to provide a reliable conclusion to study sponsors. Because Innovo Research was founded by two medical groups, our emphasis is on the "triple aim" of healthcare today:
* Improving healthcare outcomes for patients
* Reducing the cost of healthcare to patients and across the system
* Improving patient engagement and satisfaction with their healthcare experience