Regulatory and Quality Assurance Coordinator Job Summary
Responsible for clinical research regulatory and quality assurance functions of the organization, reporting to the Director of Research. Manage and oversee new study initiation process, maintaining regulatory documents. Ensure that planning, coordination and continuous improvement of processes and methods are established to control the quality of studies conducted at Park Avenue Dermatology.
Essential Duties and Responsibilities:
- Develop and compile research protocol documents and all materials required for regulatory submissions.
- Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support
- Develop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials conducted at Park Avenue Dermatology.
- Maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents.
- Stay current on federal, state and local regulations regarding clinical research and communicate changes to study staff and recommend related changes.
- Actively lead or assist activities in the areas of Internal Quality Audits, and CAPA (Corrective and Preventive Actions).
- Lead auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, agency regulations.
- Lead or assist with identifying deviations from trial protocol, provide suitable recommendations and facilitate ongoing quality improvements
- Assist with management of audits and monitoring.
- Assist in providing training to staff.
- Review vendor supplied data and quality records for conformance and good documentation practices (GDP).
- Perform other related duties as assigned.
Attention to detail
Please send resume and references to – firstname.lastname@example.org