[Remote] Specialist, Clinical Quality Assurance

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company 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 reputed company 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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