Kerry Beckett is a Senior Manager, Clinical Affairs at AlvaMed. Kerry has more than 15 years of experience managing and supporting clinical research, regulatory affairs and quality assurance projects. Kerry held senior level specialist roles in clinical, regulatory and quality affairs prior to joining AlvaMed. She has assisted clients throughout North America, South America, Europe, and Asia:
- Drafted EU-MDR 2017/745 compliant Clinical Evaluation Plans and Reports, including device classification, literature search protocols and reports, and benefit/risk analysis. Kerry has also supported client’s in the areas of Post-Market Clinical Follow-Up development and Post-Market Surveillance data generation and reporting (including Post-Market Surveillance Plans, Reports, and Periodic Safety Update Reports).
- Supported FDA Investigational Device Exemption (IDE) and 510(k) submissions for clients. Kerry has generated documents such as protocols, product documentation, informed consents, and data forms to support submissions to the FDA.
- Performed and supported submissions for clinical trials for multiple clients in the following locations: USA/EU/Canada/Argentina/Mexico. Kerry has worked with governmental entities, Investigational Review Boards (IRBs), and Ethics Committees (ECs).
- Designed and executed multiple clinical trials documents for multiple clients. Kerry has developed clinical investigation protocols (CIPs), informed consents (ICFs), investigator’s brochures (IBs), case report forms (CRFs), source data worksheets, study logs, regulatory binders, patient binders, monitoring plans/documents, safety plans/documents, study training slides, and other study-related documents.
- Developed, implemented, and maintained clinical data management systems/electronic data capture programs (EDCs). Kerry has designed multiple EDCs and databases utilizing several different programs, and has created customized coding and reports for clients requiring data collection support in clinical trials.
- Managed clinical files including trial master files, regulatory trackers, budget trackers, and site invoicing for clients conducting clinical studies.
- Conducted clinical monitoring both remotely and at the site level for clients. Kerry is an experienced Clinical Research Associate and conducts site qualification/evaluation, site initiation visits, routine interim monitoring visits, and site close-out visits.
- Designed, populated and managed ISO 13485 compliant Quality Management Systems for clients.
Kerry holds a B.S. in nutrition from Texas State University and is certified by the Society of Clinical Research Associates (SoCRA) as a Clinical Research Professional (CCRP®).
