Duke University - Durham, NC

posted 2 months ago

Full-time - Mid Level
Remote - Durham, NC
5,001-10,000 employees
Educational Services

About the position

The position involves evaluating clinical research processes and documentation to ensure compliance with regulations and study-specific requirements. This role is foundational to the audit program at DCRI and includes various quality management activities.

Responsibilities

  • Independently plan, conduct and manage all audit related activities for internal audits, vendor audits, and clinical site audits.
  • Plan and conduct internal audits to ensure compliance with sponsor protocols, standard procedures, and regulations.
  • Prepare and distribute audit reports and Audit Observation Reports to auditees, reviewing responses and CAPA plans.
  • Conduct external audits of subcontractors for vendor evaluation and prepare audit reports.
  • Plan and conduct clinical site audits to ensure compliance with sponsor protocols and regulations.
  • Facilitate sponsor audits and serve as the primary interface with sponsor auditors.
  • Plan and facilitate regulatory inspections, serving as the primary interface with inspectors.
  • Apply ICH E6(R2) Risk Management principles to identify and manage study risks and quality incidents.
  • Lead process improvements and revisions of Quality System Documents (QSDs).
  • Consult with study teams to develop Quality Agreements and provide regulatory compliance consulting.

Requirements

  • BA/BS in a scientific discipline; advanced degree preferred.
  • Minimum of 6 years' experience in pharmaceutical, medical device, biotech, or clinical trial contract research industry, including 2 years in Quality Assurance or Regulatory Compliance.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication and interpersonal skills.
  • Detail-oriented with good organizational traits and results-oriented mindset.
  • Good computer skills and inclination to adopt technology for efficiency.
  • Self-motivated with strong leadership abilities.
  • Knowledge of drug development and clinical trial processes.
  • Familiarity with relevant regulations (21 CFR, ICH E6, etc.).
  • Ability to independently travel up to 50% based on business needs.

Nice-to-haves

  • Certified Quality Auditor (CQA) and/or US Regulatory Affairs Certification (RAC US) is a plus.

Benefits

  • Remote work opportunity (specific states only).
  • Diversity and inclusion initiatives.
  • Professional development opportunities.
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