Kenny Bayo

Lead Clinical Research Associate

Role
Clinical Research Associate at Sierra Clinical Services
Location
Laurel, MD, US
LinkedIn followers
500 followers
Healthcare & Human ServicesView LinkedIn profile

About Kenny Bayo

AboutI am an experienced Senior Clinical Research Associate that interfaces with sponsor representatives and study teams to ensure timely initiation and completion of clinical trials while assuring all regulatory compliance. I act as the primary site contact throughout all phases of a clinical research study, taking overall responsibility of allocated site\'s data verification and accurate reporting.MY BACKGROUNDMy advanced knowledge of on-site monitoring enhanced by experience in tracking study progress in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents, have brought me to developing strong site relationships through all phases of clinical trials.TECHNICAL PROFICIENCYClinical Trial Management System (CTMS), Microsoft Office, Electronic Trial Master File (eTMF), Electronic Data Capture (EDC), electronic informed consent solutions (eICF), Electronic Clinical Outcome Assessment (eCOA), electronic patient-reported outcome (ePRO) data collection tools, Computer Packages, Database management, Expert programming, Microsoft Excel, Outlook, MS Project.CORE COMPETENCIESSite management, Risk-Based Monitoring, trial monitoring, and coordination, In-depth knowledge of ICH-GCP, presentation skills, project management, protocol management, quality assurance, FDA Audit Preparation/ResponsesSkills - Collaborative, High Integrity, Leadership, Problem Solving, Excellent Spoken & Written Communication INDUSTRY KNOWLEDGECase Report Forms (CRFs) data integrity, monitoring visits, project management, protocol adherence, Standard Operating Procedure (SOP) compliance, On-going regulatory document review, site personnel training, ICH-GCP, Serious Adverse Event (SAE)THERAPEUTIC AREAS Oncology– (Prostate Cancer, Small Cell Lung cancer, Solid Tumor - Breast Cancer)Respiratory-(COPD, Allergic Rhinitis)Medical Device– (Pacemaker, IVD, TAVR, Amplatzer PFO Occluder)CNS-(Parkinson, Pain, Multiple Sclerosis, Alzheimer)Infectious Disease- COVID-19 - Vaccine- HIVRare Disease- Cystic FibrosisOphthalmology- Glaucoma, Retina, Dry Eye DiseaseDermatology - Male and Female Androgenic Alopecia, Atopic Dermatitis, Acne, Nonmelanoma Skin Cancer, Gorlin Syndrome (Basal Cell Nevus/Syndrome), Psoriasis, Wound Healing

Experience

  1. Clinical Research Associate

    Sierra Clinical Services

    Sep 2023 — Present

    perform study site management,• monitoring at study sites (SQVs, SIVs, IMVs, COVs), • remote monitoring/SDV, • review study data and clinical findings, query management,• frequent communication with sites, sponsors and cross-functional team, • track study enrollment progress and subject follow-up, • review and track safety events and protocol deviations, • create study progress reports, prepare study documents, • collect and review essential study documents, attend meetings, QC audits

Education

  • University of Lagos

    Bachelor's degree, Real Estate Development

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Kenny Bayo — Clinical Research Associate at Sierra Clinical Services in Laurel, MD, US | Unifers