Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of community oncologists and the patients they serve.

Job Description:

The Research Quality Auditor will report to the Manager, Research Quality. This individual will collaborate with various OneOncology Research Network (OneR) teams and OneOncology practices to support clinical research across the OneR network. The Research Quality Auditor plays a vital role in ensuring the integrity, accuracy, and compliance of clinical trials with established regulations and standards.

The Research Quality Auditor is responsible for evaluating clinical trials for compliance with Good Clinical Practice (GCP), regulatory requirements, quality standards, and best practices throughout the lifecycle of clinical trials. This position ensures that clinical trials are conducted, recorded, and reported in accordance with GCP, while also ensuring that data integrity is maintained. This position requires a keen eye for detail, strong analytical skills, and a deep understanding of clinical research processes and regulations. The Research Quality Auditor also supports quality management initiatives and contributes to continuous improvement efforts to enhance the overall quality and integrity of research.

Key Responsibilities

• Plan, organize, and conduct GCP audits of network sites and clinical trial systems/processes

• Contribute to the audit schedule and prepare audit plans, using a risk-based approach

• Inspect trial records, data, documentation, and facilities to ensure compliance with GCP guidelines, regulatory requirements, site SOPs, and the protocol as applicable

• Lead audit kickoff and wrap-up meetings; interview clinical site staff (investigators, coordinators, etc.) to assess processes, procedures, and adherence to regulatory standards

• Document audit observations via standardized tools

• Prepare audit reports that detail nonconformities and findings and provide required actions and/or recommendations for bringing the site back into compliance as applicable

• Track audit findings and required actions through to resolution, including assisting in Corrective and Preventive Action Plan development and process improvement as applicable

• Ensure audit documentation is accurate, complete, and organized

• Prepare periodic reports and metrics to communicate audit status and relevant outcomes to relevant stakeholders and OneR leadership

• Participate in qualification activities and audits of network-level vendors by performing vendor risk assessments, liaising with vendor representatives to complete vendor questionnaires, and working with cross-functional OneR teams (e.g., Operations, Research Product) to establish vendor oversight plans

• Identify areas for improvement in site-level and network-level processes and procedures

• Stay informed of current clinical trial regulations, requirements, and guidance from FDA, ICH, and other relevant regulatory authorities

• Support regulatory inspections, sponsor/CRO audits, and inquiries by preparing documentation and addressing findings as needed

• Participate in audit- and inspection-readiness activities

• Assist in the development, implementation, and maintenance of quality management systems to ensure compliance with regulatory requirements, industry standards, and organizational policies

• Participate in the development and review of SOPs and work instructions to promote consistency and compliance in clinical research operations

• Assist in developing training materials and resources to enhance research staff understanding of practical application of regulatory requirements and best practices

• Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer.

Key Competencies

• Strong attention to detail

• Ability to make critical and objective assessments and sound judgement calls

• Demonstrated problem-solving and analytical capabilities

• Excellent written and verbal communication skills

• Excellent interpersonal and organizational skills to create and maintain effective working relationships within OneR and with OneOncology practice partners

• Ability to initiate assigned tasks and work independently

• Ability to manage multiple projects in various stages and adhere to timelines

Qualifications

• Minimum of 3-5 years of experience in clinical research, including at least 2 years of clinical trial auditing experience

• Bachelor’s degree required

• Demonstrated knowledge of GCP, FDA regulations, ICH guidelines, and clinical trial quality assurance auditing techniques

• Experience supporting FDA inspections highly preferred

• Proficiency in Microsoft Office applications and familiarity with quality management systems, electronic data capture (EDC) systems, electronic regulatory binders, and clinical trial management systems (CTMS)

• Clinical research and/or quality assurance certification highly preferred

• Remote (U.S.-based) with ability to travel ~25% (mostly within the southeastern U.S.)

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