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

Requirements

  • 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 apply@samumed.com. 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.