Kerry Beckett, clinical and quality affairs manager, has more than 7 years of experience managing and supporting clinical research, regulatory and quality assurance projects. Kerry held a senior level specialist role in clinical, regulatory and quality affairs prior to joining AlvaMed. She has experience conducting clinical monitoring – both remotely and at the site level. She also designs, implements, and maintains clinical data management systems. Kerry has expertise in building and managing clinical trial master files and clinical document creation. She also has experience designing, populating and managing ISO 13485 compliant Quality Management Systems for startup medical device companies. Kerry is experienced in supporting 510(k) and IDE regulatory submissions.
Kerry’s qualifications include the following:
- Created and managed Clinical Trial Master Files for clients.
- Developed and updated clinical documents such as procedures, clinical protocols, investigator brochures, monitoring plans, case report forms, and study logs.
- Created clinical analysis reports, clinical event reports, and conducted clinical literature reviews.
- Qualified clinical sites and conducted site and remote monitoring of study data.
- Created and maintained multiple clinical databases (both manual and EDC).
Quality Management Systems
- Created, populated, and maintained ISO 13485 compliant quality management systems and successfully achieved ISO certification for those clients.
- Developed and updated procedures to comply with ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOR/98-282 and CMDCAS standards.
- Conducted quality audits in accordance to ISO 13485, 21 CFR 820, MDD 93/42/EEC, SOR/98-282 and CMDCAS standards.
- Performed document control for ISO 13485 compliant quality management systems.
- Supported 510(k) and IDE writing and submission.
- Supported the drafting and submitting of technical bulletins.
- Supported Ethics Committee submissions for Clinical Trials.
Kerry holds a Bachelor of Science in Nutrition from Texas State University and is certified by the Society of Clinical Research Associates (SoCRA) as a Clinical Research Professional (CCRP®).
Office: (888) 33 – 13485 Ext. 2