Senior Associate, Clinical Quality Assurance

San Diego, CA

  • Samumed is looking for an experienced and talented Senior Associate, Clinical Quality Assurance to join its Quality Assurance team. 
  • This position will assist in establishing and managing processes to control the quality of clinical studies conducted by Samumed.
  • Responsibilities include ensuring adherence to the agency regulations, GxP, Industry Guidelines, local regulations, and internal policies and procedures for the conduct of clinical trials.
  • This position works closely with Clinical Operations, Data Management, other supporting areas/teams as, well as site investigators and coordinators to ensure study compliance.
  • This position will be based in Samumed’s San Diego office. 

Specific Responsibilities

  • Performing routine and non-routine quality assurance audits to include: clinical investigator sites, vendors, process, system, study project and document reviews to assure quality assurance compliance with regard to all internal procedures, as well as regulatory guidelines
  • Regularly coordinating with Clinical departments to maintain the Clinical QA (CQA) audit schedule and generate audit plans
  • Maintaining CQA vendor and audit files
  • Supporting the preparation, coordination, and management of regulatory agency inspections for Samumed
  • Assisting in preparing investigational sites for regulatory inspections
  • Managing and maintaining QA controlled documents and training systems
  • Providing QA support to internal staff and external vendors/clinical sites to ensure compliance to SOPs, protocols and relevant Good Clinical Practice (GCP) requirements
  • Developing, revising, and reviewing procedures and other controlled documents
  • Ensuring the timely and effective follow up of all identified or assigned quality issues
  • Developing and implementing GCP/ICH training for internal staff


  • B.A. or B.S. degree or equivalent experience in a scientific, nursing, or related discipline
  • 2 or more years in the pharmaceutical clinical research industry or related experience
  • Excellent communication and interpersonal skills
  • Clinical site and vendor auditing experience
  • Knowledge of U.S. and international regulatory standards and guidelines preferred
  • Familiarity and experience with computer validations requirements and 21 CFR Part 11 preferred

Please submit your resume or additional inquiries to Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded.