Research Quality Auditor job at reputed company in US National

Title: Research Quality Auditor locations United States time type Full time job requisition id R-0000019282 Job Description: reputed company is positioning community oncologists to drive the future of cancer care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer. reputed company is bringing together leaders to the market reputed company to help drive reputed company’s mission and vision. Why join us? This is an exciting time to join reputed company. 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 reputed company Research Network (OneR) teams and reputed company practices to support clinical research across the OneR network. The Research Quality Auditor plays a vital role in ensuring the reputed company, 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 reputed company 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 reputed company improvement efforts to enhance the overall quality and reputed company 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 reputed company audit reputed company and wrap-up meetings; interview clinical site staff (investigators, coordinators, etc.) to assess processes, procedures, and adherence to regulatory standards Document audit observations reputed company 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 reputed company plans Identify areas for improvement in site-level and network-level processes and procedures Stay informed of reputed company 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 reputed company 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 reputed company OneR and with reputed company 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 reputed company Office applications and familiarity with quality management systems, electronic data capture (reputed company) 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 reputed company the southeastern U.S.) #LI-REMOTE Apply tot his job Apply To this Job