Ossy Scott
Summary
Clinical Research Associate with over 6 years of experience in coordinating multi-site clinical trials, ensuring compliance with Good Clinical Practice (GCP), and maintaining data integrity. Passionate about advancing medical research, and fostering strong relationships with study sites.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate
ICON
03.2021 - Current
- Performs onsite Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities as assigned to ensure facilities are adequate, investigative site staff are adequately qualified and the site’s activities are following the clinical trial protocol and all applicable governmental and regulatory/ethics regulations
- Reviews study data, Case Report Forms (CRFs) or Electronic Case Report Forms (eCRFs), against site source documentation and discusses discrepancies with investigative site staff
- Communicates with assigned clinical research investigators and staff on a regular basis, documenting the correspondence as per the study specific guidelines
- Reviews regulatory documentation/file at the site for completeness, collects updated forms as applicable
- Trains investigative site staff as necessary
- Provides regular updates to project manager regarding the status of assigned sites (i.e., screening, enrolment, etc.)
- Notifies project manager immediately of any suspected fraudulent and/or misconduct activities
- Attends team/sponsor teleconferences and/or training meetings as required
- Attends investigator and/or study coordinator meetings, assists with event planning, develops documents/handouts, and/or participates as needed
- Attends and completes CRA field evaluations and assists with creation of CRA training tools
- Assists with review of trip reports for the project team.
Home Based Clinical Research Associate
ICON
01.2018 - 03.2021
- Maintained Regulatory Document Guidelines and Trial Master File (TMF) Plan
- Participated in TMF and on-site audits as requested; Responsible for assisting with the submission of regulatory packages to ethics committees and/or competent authorities
- Assumed responsibility for site management and site staff performance including: monitoring all types of clinical trials and participated in all types of site visits
- Ensured effective patient identification and recruitment plan as per protocol requirements
- Ensured timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations
- Performed source data verification per contractual requirements
- Assured timely completion and submission of Case Report Forms per Clinical Monitoring Plan and/or Data Management Plan
- Completed and submitted visit reports per SOP/Works Instructions (WI) requirements
- Maintained awareness of key study performance indicators for own sites, e.g
- Telephone Communications Reports, patient enrolment, and SAEs
- Prepared for and attended Investigator meetings; present materials as requested
- Assisted with the preparation of study start up materials and tools
- Attended clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions per the project communication, monitoring, and/or training plans.
Clinical Study Coordinator
Emory University Teaching Hospital
04.2014 - 12.2017
- Informed subjects on the process of informed consent, institutional guidelines as well GCP
- Maintained required records with CRF, EDC, IVRS, regulatory and temperature logs
- Scheduled subjects in a timely manner to perform all screening procedures and arranged shipment of sample boxes with a suitable air freight carrier and contacted collaborators or sponsor personnel to coordinate shipments and verified receipt of samples and keep records
- Responsible for lab compliance including Environmental Health and Safety (EHS) and Radiation Safety Compliance (RSC)
- Dispensed investigational products, calculated dosages and provided patient education
- Performed drug accountability.
Education
Bachelor of Science - Concentration in Economics
University of Calabar
Skills
- Clinical Monitoring and Phase I, II, III experience
- Experience with Oncology, CNS, Infectious Diseases, Ophthalmology, Medical Device, Vaccine
- Indications: Solid Tumor, hematology, Lung Cancer, Dementia, Migraine headaches, Influenza, genital herpes, Cataracts, glaucoma, Cardiac Pacemaker, COVID-19
Certification
- Good Clinical Practice Certification (21 CFR Part 11 Training Whitehall)
- Dangerous Goods Training/ IATA Training
- Clinical Research Associate Certification
Project Skills
- Clinical Monitoring and Phase I, II, III experience.
- Experience with Oncology, CNS, Infectious Diseases, Ophthalmology, Medical Device, Vaccine.
- Indications: Solid Tumor, hematology, Lung Cancer, Dementia, Migraine headaches, Influenza, genital herpes, Cataracts, glaucoma, Cardiac Pacemaker, COVID-19.
Timeline
Senior Clinical Research Associate
ICON
03.2021 - Current
Home Based Clinical Research Associate
ICON
01.2018 - 03.2021
Clinical Study Coordinator
Emory University Teaching Hospital
04.2014 - 12.2017
Bachelor of Science - Concentration in Economics
University of Calabar
Similar Profiles
Michelle DavisMichelle Davis
Associate Director, Post-Trial Access at ICONAssociate Director, Post-Trial Access at ICON
Jessica L. PackwoodJessica L. Packwood
Senior Clinical Research Associate I at ICONSenior Clinical Research Associate I at ICON
Aaron ParisAaron Paris
Design Manager at IconDesign Manager at Icon
Sylvesta Hildegard HlopheSylvesta Hildegard Hlophe
Senior Clinical Trials Associate at ICONSenior Clinical Trials Associate at ICON
Henrietta T. BaahHenrietta T. Baah
Senior Clinical Research Associate II/ Lead Clinical Research Associate at Fortrea (Formerly LabCorp Drug Development)Senior Clinical Research Associate II/ Lead Clinical Research Associate at Fortrea (Formerly LabCorp Drug Development)