Clinical Quality Auditor (GCP Specialist) - Low Travel/Top $$

Job Type: 
Clinical Research and Development
Quality Assurance and Quality Control
Employment Category: 

Our client, an RTP-based pharmaceutical firm that is undergoing significant growth, is actively recruiting for a skilled, knowledgeable and compliant Clinical Quality Auditor to support the QA Clinical Manager regarding all clinical development activities.   This role will start as a contract with the intent of converting to direct hire.  Company will pay industry-leading wage to attract a star.

This company has multiple products in development and an approved compound.  It is essential that the right people are in place to ensure clinical processes are conducted in accordance within SOPs and GCP guidelines.  This Auditor will play a key role.

This position will support the Clinical Quality Assurance program to ensure clinical operations and clinical trials are conducted in accordance with regulation and protocol.  The select candidate will be involved with the preparation, conduct and review of GCP audits of investigator sites, vendors, clinical study reports and internal systems and processes.  We seek a detail oriented and capable GCP Auditor who will be responsible for supporting the activities related to the QA clinical program.

This is an office-based position in the RTP, NC area with low travel. 

Duties will include:

  • Involvement in the preparation and conduct of investigator site audits, documents, databases, vendors and internal systems audits
  • Preparing for and assisting with the conduct of audits of clinical and regulatory documents, including Trial Master Files and Clinical Study Reports
  • Supporting the development of GCP-related quality system SOPs
  • Participating in internal and external meetings to discuss audit findings
  • Involvement in maintaining databases for audit observations and CAPAs, to include tracking, reviewing, approving and assessing CAPAs
  • Developing, reviewing and updating Clinical Quality SOPs with management guidance

The right candidate will bring knowledge of GCP, FDA / ROW and ICH regulations and practices with a proactive and get things done work style. 

Other priorities include:

  • Bachelor’s Degree in a scientific discipline
  • 8+ years of experience in clinical research, with 5 years of experience with QA Clinical (GCP) audits and compliance
    • GCP auditing experience
  • Strong oral and written communication skills
  • Ability to successfully work with cross-functional teams
  • Excellent organizational skills and the ability to work on multiple projects under tight timelines

Finally, and critically, we seek a candidate who will thrive in a fast-paced setting; one who has proactive and thoughtful “juggling” skills and the ability to handle a high level of activity in an evolving and exciting setting.   

For more details, please forward resume for prompt consideration.