The primary responsibility for this position will be managing/directing the Clinical QA activities to support GCP and Clinical Trial obligations.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Meet the ongoing needs of the quality assurance department by maintaining CQA compliance for ongoing and planned clinical trials.
- Lead investigations and write CAPAs on GCP issues as they arise.
- Ensure proper maintenance of the Quality systems.
- Directly interface with Clinical Operations to provide support for vendor, site, and internal GCP audits.
- Work with clinical operations and regulatory affairs to review IND and NDA submission documents.
- Responsible for ensuring submission data and documentation meets GCP guidelines.
- Perform and/or support audits of clinical sites, CROs and other clinical vendors.
- Assist in authoring clinical operation SOPs and processes as needed.
- Develop and support established records management procedures.
- Provide input and change management for quality improvements affecting CQA systems.
- Assist with writing and editing documents needed for the clinical quality management system.
- Update and maintain CQA SOPs that support the quality systems.
- Manage and update electronic libraries.
- Facilitate meetings with CRO's and other clinical entities as appropriate.
- Ensure Trial Master Files are maintained within standards.
- Other duties as assumed or assigned.
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Bachelor's degree
- Education and experience in an FDA-regulated environment.
- Ten (10) years of related quality or clinical experience in a similar environment.
- Broad knowledge of clinical processes and procedures, electronic documentation systems, and Good Clinical Practices 21CFR Parts 50, 56, and 312.
- Demonstrates initiative and proactively provides collaborative support to the clinical teams.
- Ability to plan and organize work in an efficient manner and work well under time constraints.
- Demonstrates effectiveness in maintaining CQA control systems for compliance with FDA regulations.
- Must have experience using MS Office
- Experience in MasterControl or a similar ECM system is a plus.
- Willing to travel 20-30%.
This is a fast-paced environment with moderate noise level. Limited travel may be required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines