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Clinical Research Quality Specialist
4 months ago
OneOncology 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. Our team is bringing together leaders to the market place to help drive OneOncology's mission and vision.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 Clinical Research Quality Specialist will report to the Manager, Clinical Research Quality. This individual will collaborate with OneR operations team and OneOncology practices to support clinical research across the OneOncology network. The Clinical Research Quality Specialist is a vital member of the OneR research team responsible for ensuring adherence to quality standards, regulatory requirements, and best practices throughout the lifecycle of clinical trials. This position requires a keen eye for detail, strong analytical skills, and a deep understanding of clinical research processes and regulations. The Clinical Research Quality Specialist works closely with cross-functional teams to support quality management initiatives, conduct audits, and drive continuous improvement efforts to enhance the overall quality and integrity of clinical research activities.ResponsibilitiesAssist in the development, implementation, and maintenance of quality management systems to ensure compliance with regulatory requirements, industry standards, and organizational policiesParticipate in the development and review of standard operating procedures (SOPs), work instructions, and quality documents to promote consistency and compliance in clinical research operationsConduct routine reviews and assessments of clinical trial documentation, data, and processes to identify areas for improvement and ensure accuracy, completeness, and complianceStay informed about current regulatory guidelines and requirements from FDA, EMA, ICH, and other relevant regulatory authoritiesAssist in the interpretation and implementation of regulatory requirements to ensure adherence to applicable laws and guidelines throughout the clinical research processSupport regulatory inspections, audits, and inquiries by preparing documentation, facilitating site visits, and addressing findings as neededAssist in developing training materials and resources on best practices in clinical researchParticipate in the delivery of training sessions to clinical research staff to enhance their understanding of quality standards, regulatory requirements, and organizational policiesProvide guidance and support to clinical research personnel on quality-related issues, procedures, and documentation requirementsAssist in the planning, execution, and follow-up of internal and external auditsPrepare audit plans, checklists, and reports to document audit findings, observations, and recommendations for corrective and preventive actionsAssist site research staff with process improvement needs identified through auditsCollaborate with stakeholders to track and monitor the implementation of corrective and preventive actions to address audit findings and ensure compliance with regulatory requirementsMaintain accurate and comprehensive documentation of quality assurance activities, audit findings, corrective actions, and preventive measures in accordance with established procedures and timelinesPrepare periodic reports and metrics to communicate the status of quality management activities, compliance initiatives, and audit outcomes to relevant stakeholders and managementKey CompetenciesDemonstrated problem-solving and analytical capabilitiesSolid understanding of Good Clinical Practice (GCP) guidelines, FDA regulations, and other applicable regulatory requirements governing clinical researchStrong attention to detail, analytical skills, and problem-solving abilities.Excellent communication, interpersonal, and organizational skillsAbility to work independently and collaboratively in a fast-paced, team-oriented environment.Ability to work cross-functionally to deliver on key initiativesQualificationsMinimum of 2-3 years of experience in clinical research, quality assurance, or regulatory affairsBachelor's degree in a relevant scientific discipline requiredProficiency in Microsoft Office applications and familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS) preferredAbility to travel ~25%Bachelor's degree in a relevant scientific discipline required#LI-LK1
