Overview
Work History
Education
Skills
Therapeutic Experience
Computer Experience
Timeline
Generic

Lorean Yetunde Sotome

Kearny,NJ

Overview

12
12
years of professional experience

Work History

Senior Clinical Research Associate

ProPharma
06.2023 - Current
  • Responsible for conduct of all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person, and remote
  • This includes evaluation, site initiation, interim and close out monitoring visits
  • Responsible for monitoring report writing and completion within required SOP and local regulatory parameters
  • Supports development of study specific documentation related to monitoring activities as assigned
  • This includes but is not limited to monitoring trackers, clinical monitoring guideline, clinical monitoring plan, source document templates, site tools, and worksheets, etc
  • Responsible for all site personnels/management and training on all the protocol requirements, proper source documentation procedures compliance, and case report completion requirements
  • Responsible for source document and case report forms review for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
  • Managing, preparing, sending, tracking, and returning investigational supplies as assigned
  • Includes monitoring and documenting investigational supplies dispensing, inventory, and reconciliation

Senior Clinical Research Associate

Ocugen Inc
03.2022 - 06.2023
  • Assist study management team to ensure that studies are conducted in adherence to study protocols, applicable SOPs, ICH/GCP guidelines and government regulations
  • Assist study teams in the identification, feasibility assessment, qualification, and selection of clinical research sites
  • Served as lead CRA to drive the study start-up process in conjunction with the CRO ensuring timely submission of regulatory documents and completion of clinical trial agreements and budgets
  • Interface with clinical sites to ensure timely and accurate completion of study tasks including entry of study data and resolution of data queries
  • Interface with CRO monitors ensuring CRA training, execution and reporting of monitoring visits and follow up on monitoring visit action items
  • Assisted with driving recruitment/retention follow-up with clinical study sites to support and achieve enrollment goals
  • Proactively identified risks, developing and implementing mitigation plans as applicable with assistance
  • Draft and assisted with preparation of study-related documents, tools and templates
  • Provided oversight of TMF including compliance with the TMF plan and TMF reconciliation
  • Participate in study and department meetings
  • Prepares agendas and minutes and maintains key decision and action item logs
  • Partially assisted with study team and department with financial tracking and reporting which may include coordination of CRO, vendor, and site contracts

Clinical Research Associate II

LabCorp Drug Development
01.2019 - 02.2022
  • Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; liaise with vendors; and other duties, as assigned
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
  • Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines
  • Prepare accurate and timely trip reports
  • Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management
  • Update, track and maintain study-specific trial management tools/systems
  • Generate and track drug shipments and supplies, as needed
  • Track and follow-up on serious adverse events as assigned
  • Implement study-specific communication plan as assigned
  • Attend investigators' meetings, project team meetings and teleconferences, as needed

Clinical Research Associate I

LabCorp Drug Development
09.2017 - 01.2019
  • Performed site qualification, site initiation, interim monitoring, site management and close out visits
  • Tracked and followed up with Serious Adverse Events (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Ensured the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
  • Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Prepared accurate and timely trip reports
  • Performed CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management
  • Assisted with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
  • Updated, tracked and maintained study-specific trial management tools/systems
  • Generated and tracked drug shipments and supplies, as needed
  • Attended investigators' meetings, project team meetings and teleconferences, as needed

Research Coordinator

Clifton Regional Health Research (LLC)
07.2013 - 09.2017
  • Assisted with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study
  • Interacted with patient/subject and families in a courteous and professional manner
  • Reviewed all the elements of the screening process with the Principal Investigator including: inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study
  • Collaborated with and works collaboratively with various personnel within the clinical site and external agencies which may be involved in assisting with specific aspects in the study
  • Demonstrated knowledge of policies and procedures of the host institution where the study is being conducted and the regulatory requirements such as IRB and other approvals if necessary
  • Monitored any outward effects or issues regarding patient/subject safety and reported this to the Principal Investigator, Physician and Clinical Nurse; prepares AE (Adverse Effect) reports and notifies PI of AE on a timely basis

Education

Bachelors of Science - Public Health and Health Science

Montclair State University
Montclair, NJ
07.2017

Skills

  • Ability to work independently and in a team environment
  • Monitoring experience in phases I, II, III & IV
  • Proficiency in CFR and ICH/GCP
  • Experience working on global clinical trials
  • Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint)
  • Proficiency in electronic systems (CTMS, EDC, eTMF)
  • Excellent leadership skills
  • Excellent communication skills
  • Excellent organizational skills
  • Exceptional ability to plan, organize, and execute department initiatives
  • Willingness to travel up to 60%

Therapeutic Experience

  • Endovascular Surgery, Abdominal Aortic Aneurysm, Phase I
  • Neurology, MECP2 duplication syndrome, Phase I
  • Gene & Cell Therapy- Ophthalmology and Surgery, Phase I, II, III, 12 Months
  • Immunology, Vaccine, Phase II, III, 12 Months, Lupus, Phase I, 20 Months
  • Oncology, Solid Tumors, Phase I, II, 18 Months
  • Infectious Disease, HIV, Phase III, 18 Months
  • Dermatology, Plaque Psoriasis, Phase III, 18 Months
  • Central Nervous System, Major Depressive Disorder, Phase IV, 12 Months, Alzheimer Disease, Phase II, 20 Months, ADHD, Phase I, 6 Months

Computer Experience

  • EDC: Medidata RAVE, Oracle RDC, Veeva CDMS
  • CTMS: VEEVA, iMedidata, Preclarus, ClinTRak
  • TMF: Vault, ClinTrak, Trial Interactive, PhlexGlobal
  • IRT: IRTsignantHealth, Suvoda, Endpoint, Almac
  • EMR (iKnowMed, Epic Link) Electronic Notebooks (ELN's)
  • Microsoft Outlook Suite, SmartSheet, Excel Spreadsheet, applications etc.

Timeline

Senior Clinical Research Associate

ProPharma
06.2023 - Current

Senior Clinical Research Associate

Ocugen Inc
03.2022 - 06.2023

Clinical Research Associate II

LabCorp Drug Development
01.2019 - 02.2022

Clinical Research Associate I

LabCorp Drug Development
09.2017 - 01.2019

Research Coordinator

Clifton Regional Health Research (LLC)
07.2013 - 09.2017

Bachelors of Science - Public Health and Health Science

Montclair State University

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Lorean Yetunde Sotome