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 Manager, Research Quality will report to the Sr. Manager, Research Quality. This individual will collaborate with various OneOncology Research Network (OneR) teams, site leadership, and research staff to develop and lead a quality assurance program to support clinical research at the site level.

The Manager, Research Quality is responsible for leading quality assurance and research compliance activities at the site level by serving as the primary expert on current Good Clinical Practice (GCP), regulatory requirements, and site-specific operational procedures. This position requires a comprehensive understanding of regulatory requirements, industry standards, and best practices related to clinical research and ensures that all clinical research conducted at the site adheres to them. This position partners closely with the site to foster a culture of quality, integrity, proactivity, and continuous improvement.

Responsibilities

• Develop and implement a site-level quality assurance program.

• Conduct a comprehensive gap analysis of existing processes, SOPs, and operational workflows against GCP guidelines and regulatory requirements. Based on gap analysis findings, develop a robust, fit-for-purpose quality program.

• Lead the development of all site-level SOPs, work instructions, and procedural documents to ensure they are standardized, compliant, and reflective of best practices.

• Assess training needs and collaborate with site leadership to develop curricula tailored to different roles; deliver training.

• Develop risk mitigation strategies and process improvement plans to address identified risks in systems and processes and enhance the overall quality and compliance of clinical research operations.

• As part of the OneR Quality team, collaborate closely with OneR Quality Control Specialists and Research Quality Auditors in facilitating QC and audit activities and addressing findings.

• With OneR Quality team support, participate in continuous inspection readiness activities.

• Collaborate with the OneR Regulatory team regarding promptly reportable events to the IRB.

• Collaborate with the practice’s compliance department as needed to ensure consistency between practice-level and research-specific policies.

• Lead CAPA development.

• Serve as day-to-day subject matter expert and resource for site personnel regarding quality-related questions and best practices.

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

Key Competencies

• Demonstrated problem-solving and analytical capabilities.

• Demonstrated knowledge of GCP, FDA regulations, and ICH guidelines.

• Proven track record of leading quality management initiatives, driving process improvement, and developing SOPs and work instructions.

• Excellent written and verbal communication skills.

• Excellent interpersonal and organizational skills to create and maintain effective working relationships.

• Excellent leadership and change management skills.

• Proven ability to think critically, achieve results and manage multiple projects in various stages while adhering to deadline.

• Ability to work cross-functionally to deliver on key initiatives.

Qualifications

• 4-8+ years of experience in clinical research quality assurance

• Quality assurance experience on the sponsor/CRO side highly preferred

• Experience supporting FDA inspections highly preferred

• Clinical research and/or quality assurance certification highly preferred

• Bachelor’s degree required

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

• Must be based in the greater Nashville, TN area with the ability to travel regularly between Nashville area facilities; must also have the ability to travel to the site’s Chattanooga area facilities