Oversight Monitoring and Quality Assurance

Oversight and Quality Assurance of vendors, monitor activities and site performance. Includes assessment of data integrity, protocol adherence, CRF checks, review of AE/SAE reporting, protocol adherence, IRB requirement adherence, completeness of regulatory binder, IP handling and accountability, staff and site assessment, proper informed consent rendering and records, patient safety and quality of source and data collection as well as GCP/ICH guidelines, ALCOA+.

Work closely with Sponsor to ensure high quality monitoring, monitor reporting, trial execution and site relationship.

The FDA deems the responsibility of the Sponsor to ensure the study is conducted and monitored properly.

Increasingly, Sponsors are conducting Oversight visits to assess the quality of the monitoring and site performance. It is no longer acceptable just to have monitors. Sponsors need to assess the quality of the monitoring and trial execution.

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“Effective monitoring of clinical investigations by sponsors is critical to the protection of human subjects and the conduct of high-quality studies. Sponsors of clinical investigations involving human drugs, biological products, medical devices, and combinations thereof are required to provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data submitted to FDA.”

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What it takes to be effective at performing QA and Oversight visits is not only expertise of clinical research, but extensive experience out in the field. Additionally, what I bring vast medical knowledge and skill as a medical practitioner.

Specialized focus also in training Oversight Monitors. This is a highly specialized emerging field. I can help train experienced CRAs to be effective Oversight Monitors.

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Expertise highlights

• Over 22 years experience in clinical research in various positions as a Oversight Monitor, Quality Assurance Auditor, FDA Inspection Readiness Auditor, Lead-CRA, field CRA and study co-coordinator in clinical trial phases I-IV with drug, biologics and medical device trials.
• Certified Physician Assistant – Solid medical knowledge of all body systems and therapeutic fields with over 9 years experience practicing medicine as a Physician Assistant in Emergency Medicine and ENT.
• Ability to overview a large amount of data, retain details while seeing the global picture of trends, deficiencies, strengths and needs.
• Solid knowledge of industry requirements: GCP-ICH, FDA guidelines and regulations and IRB requirements.
• Oversight Monitor trainer

Identify trends in I/E’s errors to proactively correct issues with recurrent protocol deviations, identify omissions in baseline medical history, A/E’s not being captured, deficiencies in the Regulatory Binder, Source document deficiencies as well as identifying the strength in site performance, documentation and CRA monitoring.

Experience Summary 2000-present

Oversight Monitor Lead and Trainer, Lead CRA, CRA Trainer, Regional Sr. CRA, SWAT CRA, Inspection Readiness Visits, cQA Visits. Phase I-IV study trial experience as well as post-market and Registry trial experience. Adult, Geriatric and Pediatric trials. 

Therapeutic fields: Immunology/Flu Vaccine, Gastrointestinal, Dermatologic, Neurologic, Sepsis, Respiratory, Oncology, Bone Marrow Transplant Studies, Breast Cancer, Allogeneic and Stem Cell Transplantation, Multiple Myeloma, Melanoma and Colorectal Vaccine trials, Musculoskeletal, Psychiatric and Endocrine. Device: Diabetic foot ulcer/wound healing device, Inhalers, Silicone Breast Implants, Isolex CD34 cell apheresis device, PillCam. Biologics: Melanoma Vaccine Colorectal Cancer Vaccine, Monoclonal antibody injection.

• Ensure site compliance with Good Clinical Practice (GCP) and ICH guidelines, adherence to protocol, patient safety, IRB and FDA guidelines. Conduct PSVs, SQVs, IMVs, Initiation and Close Out visits according to sponsor’s SOPs. Monitor against source data and resolve queries. Regulatory document review and monitor for proper Informed Consent procedures. Drug and device reconciliation auditing. EDC system proficiency (Inform and RAVE), Covance and IVRS systems.
• Advised study team on GCP/ICH guidelines, interpretations and updates. CAPA oversight and management.
• GCP Certification (E6R2). Proficiency in Medidata RAVE, INFORM, CTMS systems, Veeva Vault, PMED, PPG, Sharepoint, CISIV, Microsoft Office. PA-C

Please contact me for current CV, references, rates and availability.