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
Malvern, PA
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
Kearny, NJ
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
Kearny, NJ
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)
Clifton, NJ
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, NJ07.2017
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