Position Overview

This position plays a key role in the delivery of the Clinical Quality program to ensure compliance with federal regulations, local regulatory authority regulations, policies and procedures, and the principles of good clinical practices. This role represents the company both internally and externally and will participate in planning, coordinating, and conducting audits, monitoring, and due diligence activities. The audit process will include identifying compliance issues that require formal attention and developing risk management strategies to avoid non-compliance. When applicable this role will assist in filing compliance reports with regulatory bodies. Job duties:
  • Ensure that all processes contributing to the performance of a clinical trial meet the applicable requirements.
  • Keep up to date with all related clinical research legislation and compliance issues.
  • Develop Standard Operating Procedures, Work Instructions, and Forms.
  • Develop training materials.
  • Coordinate auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP/ICH/ISO, industry guidelines, and agency regulations.
  • Ensure timely issuance of audit reports, audit observation forms, oversee audit response process and drive audits to closure.
  • May conduct audits of internal files, clinical investigator sites, vendors, databases, facility and clinical laboratories, systems and processes.
  • Work closely with Clinical Operations, Regulatory, Data Management, Quality, Information Technology, and other supporting areas/development teams.
  • Communicate any critical compliance risks noted from these activities to management.
  • Assist in tracking and resolving SOP, GCP/ICH and/or ISO deviations and manage corrective action investigations.
  • May work with Clinical Operations teams on clinical study execution deliverables.Perform additional responsibilities as assigned.

    1. BS/BA degree in Life Sciences.
    2. Minimum five (5) years of experience in FDA regulated industry.
    3. Knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines and their application.
    4. In depth understanding of clinical studies.
    5. Solid computer skills (i.e. MS Word, Excel, PowerPoint and Outlook).
    6. Extensive travel required locally, regionally and nationally (up to 70%).
    Desired Qualifications
    1. Master’s degree.
    2. Device experience in biotech/pharmaceutical or related area.
    3. Clinical Research or Clinical Compliance experience.
    4. Strong problem solving, risk assessment and impact analysis abilities.
    5. Flexible and able to multi-task and prioritize competing demands/workload.
    6. Excellent written, verbal and interpersonal communication skills.
    7. Ability to effectively collaborate in a dynamic environment.
    8. Ability to work independently as well as ability to work proactively and cooperatively with managers and operational staff to solve compliance issues.