[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.

Responsibilities

• Facilitate the maintenance of the START centralized Clinical Quality Management System (CQMS) across global START sites
• Monitor 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 program
• Collaborate with Compliance to review CAPA dashboards and data for trending events over time
• Support centralized efforts to prepare, conduct, and respond to external audits and/or inspections with the Global QA and site clinical operations teams
• Support internal auditing activities to identify and mitigate areas of potential risk and promote audit/inspection readiness across the US sites
• Coordinate quarterly Quality Committee and SOP Committee scheduling and agenda planning
• Review and update Standard Operating Procedures (SOPs) in collaboration with Global QA and SOP Working Group members
• Facilitate SOP training for new issuance of SOPs, SOP revisions, and harmonization initiatives
• Support special projects requiring QA input, including collaboration with centralized Clinical Training Program implementation and new site launch activities with the Integrations department
• Identify gaps in controlled documents and recommend solutions
• Assist in the preparation of quality metrics and reports
• Assist the QA Director with other clinical QA activities as required

Skills

• Bachelor's degree or equivalent experience in lieu of degree
• Minimum 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 lifecycle
• Proven experience in handling audits, inspections, and CAPA processes is required
• Additional demonstration of clinical research knowledge as evidenced by the use of either CCRP or CCRC

Benefits

• 401(k) retirement savings plan with employer match
• Eligibility for an annual performance bonus, based on role and company results
• Generous paid time off and paid holidays
• Comprehensive medical, dental, and vision coverage and optional insurance options
• Company p‑aid life and disability insurance for added financial protection
• Employee Assistance Program (EAP) providing confidential, no ‑cost support for you and your family from day one
• Flexible FSA and HSA plans to support your financial wellness
• Commitment to a supportive environment that values balance, wellbeing, and flexibility

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