[Remote] Specialist, Clinical Quality Assurance

Note: The job is a remote job and is open to candidates in USA. The START Center for Cancer Research is the world’s largest early phase site network dedicated to oncology clinical research. They are seeking a Specialist in Clinical Quality Assurance to ensure clinical operations comply with FDA, EMA, and GCP regulations, support audits, and maintain standard operating procedures.ResponsibilitiesFacilitate the maintenance of the START centralized Clinical Quality Management System (CQMS) across global START sitesMonitor event reporting and initiate the timely kick-off of Corrective and Preventive Action (CAPA) investigation and planning, including the structured completion of root cause analysis (RCA)Collaborate with Clinical Operations to monitor the timely completion and documentation of corrective and preventive actions in support of the global CAPA programCollaborate with Compliance to review CAPA dashboards and data for trending events over timeSupport centralized efforts to prepare, conduct, and respond to external audits and/or inspections with the Global QA and site clinical operations teamsSupport internal auditing activities to identify and mitigate areas of potential risk and promote audit/inspection readiness across the US sitesCoordinate quarterly Quality Committee and SOP Committee scheduling and agenda planningReview and update Standard Operating Procedures (SOPs) in collaboration with Global QA and SOP Working Group membersFacilitate SOP training for new issuance of SOPs, SOP revisions, and harmonization initiativesSupport special projects requiring QA input, including collaboration with centralized Clinical Training Program implementation and new site launch activities with the Integrations departmentIdentify gaps in controlled documents and recommend solutionsAssist in the preparation of quality metrics and reportsAssist the QA Director with other clinical QA activities as requiredSkillsBachelor's degree or equivalent experience in lieu of degreeMinimum of 5 years of experience in oncology, clinical research setting (preferably Phase I/Early Phase oncology trials)In depth knowledge of GCP, ICH guidelines, EMA and FDA regulations, and the clinical trial lifecycleProven experience in handling audits, inspections, and CAPA processes is requiredAdditional demonstration of clinical research knowledge as evidenced by the use of either CCRP or CCRCBenefits401(k) retirement savings plan with employer matchEligibility for an annual performance bonus, based on role and company resultsGenerous paid time off and paid holidaysComprehensive medical, dental, and vision coverage and optional insurance optionsCompany p‑aid life and disability insurance for added financial protectionEmployee Assistance Program (EAP) providing confidential, no ‑cost support for you and your family from day oneFlexible FSA and HSA plans to support your financial wellnessCommitment to a supportive environment that values balance, wellbeing, and flexibilityCompany OverviewThe START Center for Cancer Research is a oncology and biotechnology research company. It was founded in undefined, and is headquartered in San Antonio, Texas, USA, with a workforce of 501-1000 employees. Its website is https://startresearch.com.