Position Overview

Responsible for planning, coordinating, and managing clinical audits, monitoring departmental due diligence activities; and developing clinical research systems and processes. Responsible for overseeing the planning and implementation of clinical quality audit schedule to ensure compliance with company, ICH/GCP, company SOP’s, and applicable regulatory requirements. When applicable, assist in filing compliance reports with regulatory bodies. Job duties:
  • Build study level audit schedules and conduct site, vendor, study, and sponsor level audits.
  • Manage vendor/contractors associated with audit initiatives.
  • Ensure all processes of a clinical trial are conducted properly.
  • Collaborate with cross-functional groups including, but not limited to, Regulatory, Quality, and complaint handling to ensure Clinical Operations adherence to company policies and regulations.
  • Keep up to date with all related quality legislation and compliance issues and perform gap analysis and remediation strategy to implement within internal systems.
  • Oversee internal and external auditing activities to ensure studies are conducted in accordance with sponsor protocols, GCP/ICH/ISO, industry guidelines, and agency regulations.
  • Create quality risk management plan, audit schedules, and BIMO readiness plans for current clinical studies.
  • Communicate any critical compliance risks noted from these activities to senior management.
  • Manage the tracking and resolving of procedure, GCP and/or ISO deviations and manage Corrective Action/Preventative Action (CAPA) investigations.
  • Ensure timely issuance of audit reports, audit observation forms, oversee audit response process, and drive audits to closure.
  • Manage documented reviews and audit protocols, informedconsents, clinical study reports, investigator brochures, regulatory submission documents, and other essential study documents as assigned.
  • Manage and develop staff.
  • Manage special projects and perform additional duties as assigned.

    1. Bachelor’s degree in related field or equivalent combination of education and experience.
    2. A minimum of eight (8) years of direct clinical quality assurance experience in FDA regulated industry, including a minimum of four (4) years of Clinical Quality Assurance experience.
    3. Knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines and their application.
    4. A minimum of two (2) years of management responsibility, preferably associates in clinical research.
    5. Good management skills, with the ability to assign and monitor work.
    6. Strong verbal and written communication skills.
    7. Proficient MS office skills (e.g., Word, Excel, Power Point, Visio, Outlook, Teams, Project, etc.).
    Desired Qualifications
    1. Medical device industry experience.
    2. Experience in compliance program.
    3. Experience in designing, monitoring, and implementing clinical trials and interpreting trial results, including understanding of biostatistics and safety reporting.
    4. A minimum of four (4) years of Clinical research experience.
    5. Able to handle multiple tasks efficiently and consistently and meet deadlines.
    6. Detail-oriented.
    7. Ability to maintain strict confidentiality.