Kelechi Shere
Marietta,GA
Summary
Seasoned Regulatory Coordinator with a background in managing and overseeing regulatory compliance within various sectors of clinical research. Strengths lie in implementing GCP guidelines for smooth trial execution, facilitating audits, prompt safety reporting and proper study documentation for stakeholders and sponsors. Have contributed significantly to past positions by improving processes, collaborating with investigators to address and resolve any issues that arise in the course of studies and fostering efficient communication channels among teams. Possess strong problem-solving and organizational skills and deliver results in high-pressure environments.
Overview
8
8
years of professional experience
Work History
Regulatory Coordinator
Johns Hopkins Medicine
Baltimore, Maryland
08.2023 - Current
- Execute smooth implementation of trials from conception through study activation and collaborate with the Research Nurse, PI and Protocol compliance team on new studies to ensure timely, accurate submission to local or central IRB and sponsors
- Coordinate tracking of 30+ protocols through various IRB, cooperative group and subcommittee approval processes, evaluating for recurrent problems, developing, and implementing systems to increase efficiency
- Liase with sponsors, data managers and external study monitors to ensure Trial Master Files(TMF) including protocol deviations, Serious Adverse Events (SAEs) and all Electronic Health/Medical Records(EHR/EMR) are reviewed, approved, correct and uploaded prior to a study visit and through closeout
- Leveraging eREG system, continuously develop and maintain 40+ up-to-date regulatory binders/master files (Electronic Master Regulatory file) as well as 100+ site Standard Operating Procedures (SOPs)
- Preparation and amendment of study related documents including but not limited to Informed Consent Forms (ICFs), Case Report Forms (CRFs) and site source documents
- Review auditing plans, coordinate site initiation, monitoring and close-out visit scheduling, ensuring they meet regulatory requirements in accordance with study protocol and SOPs
- Resolve follow-up site issues and queries as required.
Analytical Method Developer (Contract)
Novartis
East Hanover, New Jersey
06.2022 - 08.2022
- Executed project involving assessment of assay variability using generated data-set comparisons from cell viability analysis equipment: NucleoCounter NC-200 and ViCELL BLU Cell Viability Analyzer
- Facilitated potency assay optimization via weekly execution of cytokine release assays, carried out data analysis towards potency evaluation of CAR products and presented results regularly at departmental meetings
- Gleaned experience working in a GCP/GMP regulated environment vis-à-vis FDA audit and regulatory submission requirements.
Scientific Officer
Federal Ministry of Health and Social Welfare (FMOH)
FCT Abuja, Nigeria
10.2018 - 09.2021
- Coordinated clinical research amongst various sites and phases of trials, enhancing efficiency and quality by twofold within a year in this role
- Conducted study trial site qualification inspections and monitoring visits to ensure compliance towards safety and well-being of participants as well as generation of credible data from the clinical research projects
- Monitored continued compliance of drug and biologic manufacturing sites with relevant regulations and guidelines through appropriate inspection activities
- Collaborated with associated consultants from the University of Chicago to develop an oncology clinical trial program in 3 Southwestern Nigerian educational institutions, organizing meetings among teams of various departments within the country and internationally
- Shouldered administrative responsibilities in budget and personnel management as well as other departments on tasks related to policymaking, intellectual property and management of lab sites
- Managed IP inventories and evaluated dossiers of drug products intended for registration by the National Agency for Food and Drug Administration and Control (NAFDAC).
IVDU Associate
National Biotechnology Development Agency (NABDA)
FCT Abuja, Nigeria
01.2017 - 07.2017
- Outlined 5+ protocol SOPs for laboratory equipment and assisted in creating the Immuno-vaccinology Vaccine Development Unit (IVDU) work plan for the recombinant vaccine laboratory reconstruction and activities
- Contributed to troubleshooting of test methods/instruments, validation protocol and reports, and performance of validation experiments to ensure accurate and dependable results
- Researched potential grants, categorized relevant information in spreadsheets and infographics and presented updates regularly at team meetings.
Education
Master of Science in Biotechnology -
NORTHWESTERN UNIVERSITY
Evanston, IllinoisBachelor of Science in Applied Biology and Biotechnology -
COVENANT UNIVERSITY
Ota, Ogun StateSkills
- Clinical Research
- Oncology
- Medical Devices
- Audit management
- SOP Development
- Documentation Management
- FDA and ICH Q10 guidelines
- Current Good Clinical Practices (cGCP)
- Effective Communication
- Analytical Skills
- Organizational Skills
- Keen Attention to Detail
- Microsoft Office suite
- CRM Software
- Project Management Software
- Database Management and Analysis
- Epic
- RAVE
- EDC
- IRT
- Vestigo
- ECRF
- EIRB
- EREG
- Veeva
- Aurora
- IRBManager
- CRMS
- CTSU
- Shared Investigator Platform
- Oncore
Leadership and Service Activities
- Vice-President, Community Development Service in Education, Health Awareness and Sanitation (CDS) group, FCT Abuja, Nigeria, 11/2018 - 10/2019, Coordinated HIV/AIDS awareness seminar for 60 public school students in and around the Federal Capital Territory, Collaborated with health professionals in the community to create volunteer opportunities for fellow corps members, Spearheaded mental health awareness and postpartum depression sensitization campaigns in rural and suburban areas
- Senate Member, Biological Sciences Students Association (BIOSSA) - Covenant University Chapter, Ota, Ogun, 09/2015 - 07/2018, Conducted tutorial classes and 3 interactive workshops per semester to deepen understanding of academic concepts, Liaised between students and lecturers in matters including but not limited to feedback information, distribution of pertinent material and organization of project work groups, Sustained a 100% attendance record for all association events, and had a consistently satisfied student body, as revealed by annual surveys
Timeline
Regulatory Coordinator
Johns Hopkins Medicine
08.2023 - Current
Analytical Method Developer (Contract)
Novartis
06.2022 - 08.2022
Scientific Officer
Federal Ministry of Health and Social Welfare (FMOH)
10.2018 - 09.2021
IVDU Associate
National Biotechnology Development Agency (NABDA)
01.2017 - 07.2017
Master of Science in Biotechnology -
NORTHWESTERN UNIVERSITY
Bachelor of Science in Applied Biology and Biotechnology -
COVENANT UNIVERSITY
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