• Senior Level Clinical Research Professional with 15+ years monitoring experience in the Medical Device, In-Vitro Diagnostic and Pharmaceutical industries. • Certified Clinical Research Associate through the Association of Clinical Research Professionals with two bachelor’s degrees in Molecular Biology and Business Management. • FDA inspections in 2008 (PMA), 2012 (NDA), 2024 (PMA) yielded zero findings at high enrolling assigned sites.• Expertise in study site qualification, initiation, interim monitoring, quality oversight and closeout visits independently according to SOPs, GCPs, FDA regulations and ICH guidelines at multiple investigational sites within specified timelines. • CV available upon request.Experienced in the below Therapeutic Areas:Cardiovascular (In Vitro Diagnostic): Emergent POC Troponin, NT-proBNP Heart Failure Cardiovascular (drug): Hypercholesterolemia (Phase IIb)Cardiovascular (device): Pulmonary Arterial Hypertension, Cardiac Rhythm Disease Management, Vascular anastomosis sealant, Drug Eluting Cardiac Stent, Carotid Stent, Total Chronic Occlusion, Distal Embolization ProtectionDigestive System (device): PillCam, Gastric Motility SmartPill, Bariatric Surgery, Surgical Staplers, Single Incision Laparoscopic CholecystectomyDigestive System (drug): Obesity GLP-1 (Phase II), MASH GLP-1 (Phase II), NASH/NAFLD (Phase III), IBS (Phase II),General (device): Tonsillectomy Ligation, Absorbable suture, V-Lock suture, Hernia Mesh, Hernia Mesh Tack Genitourinary (device): Adnexal Adhesiolysis (infertility & pain in women) Infectious Disease (vaccine): SARS-CoV-2 (Phase II/III) Nervous System/Sense Organs (device): CNS Dural Surgical Sealant, Implantable Pain Pump, Deep Brain Stimulation, Spinal Cord Stimulation Oncology (drug): Prostate Cancer (Phase III), Pancreatic Cancer (Phase III)Oncology (In Vitro Diagnostic): Next Generation Sequencing - Liquid Biopsy - All CancersRespiratory System (device): Diaphragm Pacing Therapy, Lung sealant, Surgical Staplers, Microwave Ablation of lung tumors, Electromagnetic Navigational Bronchoscopy, Opioid-Induced Respiratory Depression