Description:
Responsibilities:
- Perform comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
- Ensure data is recorded in accordance with sponsor protocol, GCP guidelines, industry guidelines and agency regulations.
- Perform quality control checks; identify and track source documentation errors and non-conformances with requirements.
- Provide ongoing compliance support including but not limited to:
- Preparing periodic clinical trial quality reports for assigned programs and assessing these reports with applicable clinical team members to identify areas of risk. Collaborates with applicable team members to develop risk mitigation plans.
- Collaborating with the Clinical Team to share audit/inspection observations for lessons learned across protocol, and/or program, and working with appropriate groups to implement Corrective Action Plans (CAPAs).
- Performs quality reviews of key documents developed for use in clinical trials and in preparation for submission to regulatory health authorities.
- Assist in preparing for all Sponsor and FDA audits.
- Assist in conducting internal audits to review key processes.
- Provides appropriate support to assigned cross-functional workgroups.
- Establishes effective partnerships with internal staff to facilitate the timely identification and resolution of compliance and quality matters and other opportunities for quality process improvement.
- Other related Quality Assurance projects as assigned.
- The QA Associate will report to the Quality Assurance Lead
Knowledge, Education, and Experience:
- Minimum Education Required – Bachelor’s Degree.
- In-depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials.
- Knowledge of IRB requirements.
- 1+ years in work related to Quality Control / Quality Assurance area in clinical research.
- Experience including external clinical/regulatory and document auditing desirable.