Sonya Dimitrova

Background

About Sonya Dimitrova

Experienced Medical Monitoring Associate in performing Medical Monitoring of phase 1-3 clinical trials and supporting Medical Directors on oncological, internal medicine and neuroscience clinical research studies. Key responsibilities: • Site interaction: Provides medical consultation under Medical Monitor guidance to therapeutic sites. Supports Medical Monitor in review of patient eligibility and medical testing/lab reports reviewed protocol deviations in CTMS (e.g. Oracle Siebel CTMS) with Medical Monitor using appropriate SOPs and procedures. • Medical Monitoring Plan - Creates Medical Monitoring Plan according to awarded budget and services, under Medical Monitor supervision. • Creates medical monitoring processes such as patient eligibility review process, lab results review process and protocol deviation review process. • Organises relevant project meetings/ teleconferences, project documentation review and performs quality review of eTMF (e.g. Veeva eTMF). • Mentored medical and clinical/ therapeutic sites' team members on medical monitoring processes and tools. Strong research professional Clinical Trials with exellent knowlege of Good Clinical Practice (ICH/GCP), all study related activities, excellent communicational skills and strong attention to details. Experienced in: • Coordination of clinical research to ensure research activities comply with federal guidelines and institutional policy. • Ensuring proper training of research personnel to comply with federal guidelines • Recording and documenting training activities of personnel • Working closely with compliance officers facilitating and reporting on clinical audits • Maintaining confidentiality and protection of patients participating in clinical research. • Documenting and reporting any breach in compliance with federal and agency regulation to appropriate persons. • Skilled in Microsoft Word, Power Point and Excell. • Licensed Practical Nurse with a Bachelor's degree from Medical college Sofia.