QA Auditor

Our Cancer Research Services team has an exciting opportunity for a QA Auditor with our corporate offices in Houston, TX. This position will be able to have a home base in St. Louis or Kansas City, MO.


SCOPE:

Under general supervision, conducts Good Clinical Practice (GGP) audit process and support for compliance with US GCP regulations and guidelines and International Conference on Harmonization (ICH) guidelines. Responsible for audits of investigator-initiated data and implementation of quality improvement plans. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Conducts standard research site audits for adherence to GCP, ICH and FDA regulatory requirements and regularly scheduled visits to audit for timeliness and quality of clinical research data.
Monitors compliance with written research operating procedures at assigned practice sites through review and audit of patient lists
Monitors data on investigator-initiated trials. Validates raw data from patient charts and audits for accuracy. Audits case record to determine if tests are completed in accordance with protocols. Audits information on CRF to ensure consistency with medical records.
Reviews site audit reports with practice-based research staff and administration and works collaboratively with Network Research Operations Managers to effect action plans.
Completes and submits written research QA site audit reports to central Quality Management and Compliance Coordinator on a monthly basis.
Develops and implements corporate-wide research QA programs at site locations. Works with sites to assist with the development of internal QA programs.
Responsible for new research site qualification with respect to company research policies and procedures. Collects information including physician CV's, clinical lab information etc.
REQUIREMENTS
Bachelor's degree in a clinical discipline, BSN preferred. Minimum five years experience in an oncology and/or research setting. Knowledge of GCP, ICH and FDA guidelines. Experience with collecting and/or reviewing data for clinical research studies. Computer proficiency with Microsoft Office Suite. Valid state licensure applicable to clinical background. CCRA or CCRC preferred.Work will require significant travel by air or automobile, approximately 80% of workweek, on average.