Summary
Overview
Work History
Education
Therapeutic Areas
Certification
Skills and Relevant Experiences
Publications
Timeline
Generic

Loretta Idowu

Reno,NV

Summary

A clinical research professional with over 6 years of experience across the following roles: Research Assistant, Molecular Biologist, Clinical Research Associate, Lead CRA and Clinical Trial Manager. Experience in Phase I – IV trials in the areas of Cell and Gene Therapy, Infectious Diseases, Vaccines, Pulmonology, Gastroenterology, and Internal Medicine (Nephrology) etc. Looking to utilize my strong clinical trial management and leadership expertise to facilitate the efficient and successful delivery of studies from study initiation to closeout, while meeting study milestones, timelines, and deliverables within budget. (Open to relocation)

Overview

8
8
years of professional experience
1
1
Certification

Work History

Contract Senior CRA/ Clinical Trial Manager

PPD
01.2024 - 04.2024
  • Lead CRA with clinical trial management responsibilities, focused on study start-up for a global phase III vaccine study
  • Collaborated with various departments to create study documents and plans such as the master project management plan, risk mitigation plan and protocol deviation plan along with creating the protocol, site initiation visit slides and other CRA tools
  • Led site feasibility, site qualifications visits, and other study start-up related tasks, resulting in first patient first visit milestone achieved 2 weeks earlier than projected
  • Collaborated on Kick-off meeting, investigator meeting planning vendor selection and vendor management
  • Trained newly assigned CRAs on the study and remained the point of escalation for all site, CRA and CTA study related questions, concerns or issues
  • Created and implemented a study specific onboarding checklist to ensure new team members are adequately trained prior to involvement in the study
  • Initiated and maintained important study logs and trackers such as the study invoice tracker, study decision log, contract changes log and FAQ log

Lead Senior CRA

Parexel International
04.2022 - 12.2023
  • Managed a Phase 3 DMD trial as a lead CRA with oversight of 7 CRAs across 60 US sites, from initiation through study closeout
  • Coordinated end-to-end clinical sample management operations, encompassing meticulous oversight of patient biological sample collection to sample analysis with timely transmission of lab reports to investigators
  • Optimized project timelines and budget, exceeding target recruitment goal and maintaining deliverables on schedule for successful FDA approval.
  • Led study team to achieve compliance by ensuring inspection-readiness per ICH/GCP standards, local regulations and study protocol, resulting in zero major findings in FDA and sponsor audits
  • Provided monitoring oversight with timely review of CRA monitoring visit, expense and time utilization reports.
  • Reduced protocol deviations and quality issues by 25% through proactive monitoring oversight, issue resolution and implementation of rigorous trainings for study coordinators.
  • Led team meetings (internal team meetings, sponsor calls and vendor calls), facilitating seamless collaboration between various cross-functional study teams
  • Successfully identified several potential operational challenges and proactively proposed resolution plans, reducing risk incidents by 50%
  • Led interim analysis and data base locks, ensuring adequate CRA and site coverage, driving timely study progress and stakeholder updates.
  • Supervised and liaised effectively with internal and external key stakeholders (Sponsor, CRA, project managers, line managers, regulatory affairs, data management, site payments, contracts and budgets and study vendors) to ensure study timelines and milestones are met while maintaining data integrity and patient safety

Senior Clinical Research Associate

Parexel International
04.2022 - 05.2023
  • Responsible for 30 sites across 2 protocols
  • Drafted/edited project plans, protocol amendments, ICF templates, eCRF completion guidelines, monitoring plan, Pharmacy manual, lab manual and manual of operations
  • Facilitated team meetings and disseminated meeting minutes across clinical team of CTMs, CRA, CTAs, IH CRAs and CRA LMs including cross functional, central monitoring, vendor, and sponsor calls/meetings
  • Tracked and escalated as needed, CRA site visits projections, ensuring study needs and data deliverables are met by advocating for co-monitors and additional days on site as needed
  • Mentored and trained junior CRAs and assessed their competency and independent monitoring ability
  • Reviewed monitoring visit reports and onboarded new CRAs
  • Performed QV, SIV, IMV and TV with both 100% and reduced source data verification, risk-based and targeted monitoring
  • Studies were both onsite and remote, utilizing both paper source and remote electronic source platforms
  • Point of escalation for assigned CRAs, collaborated with CTM, project management and medical team to address and resolve major site issues and questions in adherence to ICH/GCP, SOPs, applicable regulations, monitoring plan and study protocol
  • Facilitated and supported sites with access to relevant study/vendor systems and ensured sites were compliant with project specific training requirements
  • Reviewed test article supply, accountability, and destruction/return status
  • Addressed and resolved issues at sites, identified potential deficiencies in source and regulatory documentation, ensuring first time quality and audit readiness especially with ISF and TMF
  • Utilized RCA and CAPA to address quality issues and non-compliance at sites

CRA II

ICON PLC
03.2021 - 04.2022
  • Responsible for 4 protocols across 23 sites
  • Responsibilities included identification, selection, initiation, routine monitoring, refresher training and close-out visits of investigational sites for clinical studies
  • Monitored sites to ensure that studies are carried out according to the study protocol and the principles of ICH-GCP and regulatory requirements, from startup to close out of the study life cycle
  • Reviewed and contributed to the creation of draft protocols, eCRFs, monitoring reports, study manuals and other study related documents and templates as requested by CTM and/or PM

CRA

Medpace
09.2019 - 03.2021
  • Responsible for 5 protocols across 25 sites
  • Conducted site qualification, initiation, monitoring, and close-out visits according to ICH-GCP, sponsor SOPs, and applicable regulatory requirements for early and late phase global clinical trials with 100% SDV and risk-based monitoring
  • Obtained advanced monitoring certificates within infectious diseases, rare diseases, advanced therapeutic medicinal product, and medical device therapeutic areas
  • Appointed as peer mentor to assist new CRA hires become familiar with TIME reporting, expense reporting, CTMS, eTMF navigation and company SOP repository etc

Research Assistant

IU School of Medicine - Division of Nephrology
10.2017 - 08.2018
  • Collaborated on projects focused on understanding chronic kidney disease - mineral bone disorder as it relates to vascular calcification and bone disease in dialysis patients
  • Trained over 5 new lab employees on study protocols, lab techniques (ELISA, PCR, western blot) and good lab practices
  • Performed in vitro and in vivo animal studies to ameliorate the symptoms of chronic kidney disease by developing and testing for drugs such as phosphate binders and calcimimetic used by dialysis patients
  • Delivered results consistently from multiple concurrent projects at weekly meetings to the director of the department and principal investigators involved

Molecular Biologist

Corteva (Formerly Dow Agrosciences)
08.2016 - 10.2017
  • Led a team to develop a novel DNA extraction method for a new tissue type using Nucleo-Mag chemistry and semi-automated) for genotyping
  • This procured annual savings of about $200k
  • Cut processing time by 50% utilizing automation and operating instrumentation in critical multistep sequencing processes to support trait genomic studies
  • Optimized processes by correcting protocol errors leading to time and cost savings of over 20%, providing solutions for farmers and improved their annual crop yield by 30%
  • Worked with traditional molecular biology techniques to help develop plant-resistance varieties to plant pathogens and plant diseases using PCR and NGS
  • Performed DNA/protein extraction & quantification with attention to high-quality DNA yield and developed an SOP for fungal mycelium extraction and toxin quantification using aseptic technique working in an ISO 17025 accredited BSL-2 lab following GLP
  • Provided high throughput, high-density SNP genotyping using Illumina Infinium process -NGS sequencing
  • Facilitated high-throughput low density genotyping (384 & 1536 well plates)

Education

Master of Science - Biomedical Sciences

Marian University
Indianapolis, IN
08-2019

Bachelor of Science - Biochemistry

West Virginia University
Morgantown, WV
05-2016

Therapeutic Areas

  • Nephrology - Iron deficiency anemia (Phase II), Renal disease (Phase II), Chronic kidney disease (Phase II), Hyperphosphatemia (Phase II)
  • Gastroenterology - Irritable bowel syndrome (Phase I), Inflammatory Bowel Disorder (Phase I), Crohn’s Disease (Phase I), Ulcerative Colitis (Phase I)
  • Liver diseases - Acute Liver Disease (Phase II), Alcoholic Hepatitis (Phase II), Non-Alcoholic Steatohepatitis (Phase IIb)
  • Cell and Gene Therapy - Duchenne’s Muscular Dystrophy (Phase III), Primary Mitochondrial Myopathy (Phase III)
  • Infectious Diseases - Clostridium Difficile Infection (Phase III), Graft Versus Host Disease (Phase IV), COVID -19 (Phase III)
  • Vaccines - Pneumococcal Vaccine (Phase II), COVID-19 (Phase III, unblinded)
  • Pulmonology - Asthma (Phase II)
  • Central Nervous System - Multiple System Atrophy (Phase IV)

Certification

  • ClinEssentials Clinical Trial Management Training Course, 2023
  • Parexel Oncology Academy, 2023
  • Thermo Fisher Scientific Vaccine Academy Certificate Program, 2024
  • LinkedIn Fundamentals in Project Management Course, 2023

Skills and Relevant Experiences

·  EDC – (iMedidata RAVE, Inform), eTMF – (Veeva Vault), IWRS/IRT – (Cenduit, Flex Advantage, Calyx IRT),    eSource – (Science 37), eISF – (CRIO, Box, Florence), EMR – EPIC, CTMS (Impact Harmony, Veeva)

·  Management of central and local labs, central and local IRB.

·  Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, OneNote), Spreadsheets

Publications

  • Effects of body condition score on direct and indirect measurements of insulin sensitivity in periparturient dairy cows, Samii, S & Rico, Eduardo & Mathews, Alice & Davis, A & Orndorff, C & Aromeh, L & Mcfadden, J., 2019, PubMed
  • Effect of dietary phosphorus intake and age on intestinal phosphorus absorption efficiency and phosphorus balance in male rats, Colby J Vorland, Pamela J Lachcik, Loretta O. Aromeh, Sharon M Moe, Neal X Chen, 2018, PLOS ONE

Timeline

Contract Senior CRA/ Clinical Trial Manager

PPD
01.2024 - 04.2024

Lead Senior CRA

Parexel International
04.2022 - 12.2023

Senior Clinical Research Associate

Parexel International
04.2022 - 05.2023

CRA II

ICON PLC
03.2021 - 04.2022

CRA

Medpace
09.2019 - 03.2021

Research Assistant

IU School of Medicine - Division of Nephrology
10.2017 - 08.2018

Molecular Biologist

Corteva (Formerly Dow Agrosciences)
08.2016 - 10.2017

Master of Science - Biomedical Sciences

Marian University

Bachelor of Science - Biochemistry

West Virginia University

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Loretta Idowu