Summary
Overview
Work history
Education
Skills
Accomplishments
Timeline
Generic

PRECIOUS AGOH

Summary

Accomplished Clinical Research Associate with 2 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards. Looking for a CRA position where I can put to use my skills and experience in site management to support clinical trials and the process of drug development.

Overview

7
7
years of professional experience

Work history

Clinical Research Associate I

12.2021 - Current
  • Actively involved in field-based operations for the identification of new sites and investigators
  • Participated in site evaluation visits and provided detailed report to enhance site selection process and decisions
  • Conducted site initiation visits to provide protocol and GCP training to investigators and research personnel to ensure a smooth start to study recruitment processes
  • Carried out site monitoring visits to perform thorough and detail-oriented source data verification, drug accountability, query generation and resolution, SAE verification and reporting, site file review, confirm PI oversight and resolving action items
  • Sending follow-up letters to sites following report approval, after visit report writing within the predetermined timeframe of five days for the draft and ten days for the final version
  • Regularly communicate with study sites to ensure all clinical trial requirements are strictly adhered to in compliance with the protocol, Sponsor instructions, and applicable federal and state regulations, guidelines, and/or policies
  • Ensured essential documents are filed appropriately by comparing and reconciling between the Trial master file and the regulatory binder
  • Troubleshooting, advising, and conducting follow up on study progress with site staff and sponsor
  • Monitoring recruitment and data quality while on site and remotely through EDC systems.

Clinical Trial Assistant

Sheffield Health & Social Care NHS FT
09.2020 - 12.2021
  • Prior to study visits, set up and compile the patient notes
  • Collection and recording of study data by carrying out assessments, such as ECGs, blood pressure, pulse rate, temperature, oxygen saturation, obtaining blood samples or any other clinical assessment as required
  • Kept track of the investigator's site file
  • Ensuring the efficient operation of assigned studies
  • Data input into the eCRF system (RAVE and InForm)
  • Educating participants about the objective and procedure of the study
  • Distributing the EQ-5D-5L questionnaire to patients
  • Processing blood samples, recording temperatures, shipping ambient and frozen samples
  • Ensuring the appropriate calibration of equipment
  • Assist in the set-up of study equipment
  • Participating in initiatives aimed at recruiting study subjects.

Medical Laboratory Scientist

Emmanuel Diagnostic Laboratory
06.2017 - 07.2020
  • Worked in accordance with the Departmental Standard Operating Procedures and assist in the development and review of these as required
  • Actively involved in the reception, preparation and processing of samples submitted to the department in accordance with laboratory policies and protocols
  • Assisted in the interpretation and technical validation of the analyses in accordance with laboratory Standard Operating Procedures (SOPs)
  • Prioritised the completion of urgent requests, validated and released test results to service users as required; Telephoned/emailed important results to an appropriate person when necessary while taking into cognizance patient's confidentiality
  • Ensured adequate supplies of reagents and consumables
  • Ensured consumables and equipment are used efficiently and safely in accordance with Health & Safety policies
  • Participated in risk management of the department including the reporting of adverse incidents
  • Assisted in research and development projects as required
  • Assisted in the training and teaching of trainee biomedical scientists, new biomedical staff, medical laboratory assistants, medical staff and other healthcare professionals as required
  • Participated fully in the department's 24/7 rota service.

Education

M.Sc - Biomedical Laboratory Science

Sheffield Hallam University
Sheffield

B.Sc - Medical Biochemistry

Delta State University
Nigeria

Skills

  • On-site qualification
  • Clinical trial recruitment plans
  • Clinical trial methodology
  • Site selection
  • Study protocols
  • Good Clinical Practice (GCP) guidelines
  • Interim monitoring
  • Statistical analysis
  • Site monitoring visits
  • Case Report Form (CRF) reviews
  • Good Laboratory Practice (GLP) knowledge
  • Critical thinking
  • Patient care
  • Test data recording
  • Laboratory information management systems (LIMS)

Accomplishments

  • Years of experience in managing and monitoring clinical trials at various sites
  • 3 years of experience in hospital diagnostic laboratory as a medical laboratory scientist with extensive proficiency in the use of automated, semi-automated and manual equipment to execute a variety of laboratory investigations with a high level of accuracy and efficiency
  • Experience in the monitoring of phase I-IV global studies including site selection, maintenance, and close-out phases
  • I have a strong understanding of ICH-GCP guidelines, HRA, MHRA, and Ethics Committee
  • Along with my leadership and interpersonal skills, I have excellent oral and written communication skills
  • I am highly organized, detail-oriented, and proficient in various computer programs such as MS Word, PowerPoint, Excel, Outlook, One Note, and Access
  • Additionally, I have proficiency in the use of EDC platforms like Medidata Rave & Inform, CTMS systems like Impact, and Siebel, IWRS platforms such as BioClinica, and eTMF systems like Veeva Vault.

Timeline

Clinical Research Associate I

12.2021 - Current

Clinical Trial Assistant

Sheffield Health & Social Care NHS FT
09.2020 - 12.2021

Medical Laboratory Scientist

Emmanuel Diagnostic Laboratory
06.2017 - 07.2020

M.Sc - Biomedical Laboratory Science

Sheffield Hallam University

B.Sc - Medical Biochemistry

Delta State University
PRECIOUS AGOH