Frank Salazar

Background

About Frank Salazar

Bilingual (English/Spanish) Independent Consultant/CRA (October 1998 – Current) Pharmaceutical and Medical Device Trials Participates in the management of multi-center clinical research studies by monitoring and managing study sites and ensuring appropriate documents are properly maintained; reviews CRFs; performs drug/device accountability; assesses site adherence to protocol requirements and FDA guidelines; performs detailed visit reporting and query resolution; conducts site training. CRA works as a liaison between the sponsor and study sites during the course of clinical trials. Summary of clinical monitoring/auditing experience: 1. 15 years experience in monitoring Phase I – IV clinical trials in a variety of therapeutic areas 2. 4 years experience working in clinical trial materials 3. Audit and prepare US clinical sites for FDA and sponsor audits 4. Experience working with various EDC systems: Trialmaster/Omnicon, Lifetree, INFORM, KIKA, Clindex, Maestro, Oracle, etc 5. Monitoring and managing sites in Canada, Mexico, and European sites (Italy, France, Spain, Greece, Denmark) 6. Strong interpersonal skills with the ability to work with various departments within an organization 7. Working with sales and marketing representatives at clinical sites 8. Good working knowledge of GCP/ICH guidelines and FDA regulations 9. Clinical Specialist with physician proctoring in cath labs & angio-suites 10. Adverse Event Reporting and Tracking 11. Developing and presenting study training materials to medical staff 12. Strong organizational and analytical skills with attention to detail 13. Ability to manage multiple sites, tasks and protocols simultaneously 14. Good communication and presentation skills 15. Excellent technical writing skills and proficient in Microsoft Word, Power Point, Excel, etc Specialties: Cardiovascular Medical Devices (DES, IVUS, Embolic Protection, Dilatation Balloons, Ablation catheters, Closure Devices)