Rita Pease has over 14 years of experience in the clinical development industry, with a focus on Good Clinical Practices (GCP) compliance and auditing. She has participated in developing compounds and devices in the following roles: Study Coordinator, Clinical Research Associate, Clinical Project Manager, Senior GCP Auditor and Associate Director of Quality Assurance.

In these various roles, she has improved the quality systems of both companies and clinical research organizations (CRO) by:

• Establishing the Quality Assurance System and Department for a 100+ employee corporation.
• Managing, hosting and supporting sponsor audits and Regulatory Authority Inspections.
• Authoring and Reviewing Standard Operating Procedures (SOPs), working practices, and policies to ensure compliance to Good Clinical Practices (GCP).
• Interpreting regulatory language to provide guidance, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
• Evaluating and managing the compliance of Biotechnology, Pharmaceutical and Device trials to current GCP requirements.
• Performing audits of essential trial documents, investigator sites, clinical study reports, and systems.
• Managing pre-inspection activities.
• Coordinated 16 FDA Pre-Inspections and Site inspections internationally.
• Training Compliance Auditors and Global CRO in GCP and 21 CFR part 11.