AIMUAMWONSA DONNA OMORUYI
Union,NJ
Summary
A passionate Clinical Research Associate with over 6+ years of progressive experience working as a Clinical Research Associate on Phase I, II, III clinical studies in the therapeutic areas of Cardiovascular, Endocrinology (Diabetes), Oncology, and CNS, with strict adherence to ICH/FDA regulations. Clear communication and drive for results by site coordinators, investigators, and vendor representatives. Ability to timely collect study documentation for TMF, reconcile inpatient and outpatient source data with electronic case report forms (eCRFs), and assist in resolving issued data queries.
Overview
11
11
years of professional experience
Work History
Senior Clinical Research Associate
Direct Biologics
01.2021 - Current
- Monitors clinical trials
- Conducts site evaluation, initiation, interim and close-out visits
- Collects and reviews study data
- Assesses monitoring reports
- Verifies action items and resolution
- Tracks and documents all protocol deviations
- Creates clinical protocol implementation according to sponsor, industry, and federal guidelines
- Ensures compliance with multiple protocols, FDA regulations and ICH/GCP guidelines
Clinical Research Associate II
ICON
01.2018 - 12.2020
- Maintained a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- (Performed on-site or remotely) qualification, site initiation, interim monitoring, site management activities and close-out visits
- Verified the process of obtaining informed consent has been adequately performed and documented and ensure site staff demonstrates diligence in protecting the confidentiality of the subject/patient
- Assessed factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
- Assessed site processes, Conducted Source Document Reviewed appropriate site source documents and medical records
- Verified required clinical data entered in the case report form (CRF) is accurate and complete and apply query resolution techniques remotely and on site
- Provided guidance to site staff as necessary, driving query resolution/quality compliance issues to closure within agreed timelines
- Utilized available hardware and software to support the effective conduct of the clinical study data review and verifies site compliance with electronic data capture requirements
- Performed investigational product (IP) inventory, reconciliation and reviews storage and security
Clinical Research Associate I
ICON
05.2016 - 12.2018
- Adhered to good clinical practices, operating procedures and regulatory requirements
- Performed pre-study, closeout and interim visits to check on study activities
- Obtained site approval and compiled all vital documentation
- Supported quality control program by scheduling site assessment visits for projects and conducting monitoring visits
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion
- Liaised with clinical investigators to identify, assess and resolve site performance, quality and compliance issues
- Maintained Site Monitoring schedules to facilitate effective communication with members of the clinical team
Clinical Research Coordinator
Children's Healthcare
03.2014 - 04.2016
- Assisted with IP accountability and compliance with all study protocols as needed
- Maintained all subjects binders of documentation and Daily monitoring of IP storage temperatures
- Responded appropriately and timely with documentation of all AE's and SAE's in accordance with protocol guidelines for all studies
- Ensured that all study supplies and kits were received and documented
- Attended site initiation visits & site monitor visits in addition to other meetings for various studies
- Facilitated in developing source documents for new clinical research projects
- Responding to and answering queries of medical monitors and study sponsors
- Collected, recorded and maintained data on source documents with timely completion of Case Report Forms
Education
BA - Psychology
University of Science Arts and Technology (USAT)
Skills
- Microsoft Suite
- Project Management
- Oncology
- HIPAA
- FDA Regulations
- Good Clinical Practice (GCP)
Systemvendorexperience
- EDC: Medrio, iMedNet, Inform and Medidata Rave
- CTMS: VeevaVault and Impact
- IWRS: Sampleminded, Endpoint and Suvoda
- ETMF: Veevavault
Therapeuticareas
- Oncology: Gastric cancer, Non Small Cell Lungs Cancer, Solid Tumor and Colon Cancer
- Endocrinology: Addison's Disease and Diabetes
- Cardiovascular: Pericardial disease
- CNS: Parkinson's disease and Multiple Sclerosis
Timeline
Senior Clinical Research Associate
Direct Biologics
01.2021 - Current
Clinical Research Associate II
ICON
01.2018 - 12.2020
Clinical Research Associate I
ICON
05.2016 - 12.2018
Clinical Research Coordinator
Children's Healthcare
03.2014 - 04.2016
BA - Psychology
University of Science Arts and Technology (USAT)
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