Olive Obi
Glendale Heights,United States
Summary
Results-driven Clinical Research Associate with 2 years of hands-on experience overseeing clinical trials across diverse therapeutic areas, with a proven ability to navigate complex clinical protocols while ensuring full compliance with ICH-GCP and international regulatory standards. Recognized for a meticulous eye for detail, a strong commitment to patient safety, and a consistent track record of ensuring protocol compliance and contributing to successful trial outcomes. Skilled in leveraging data analysis and clinical IT systems, EDC, CTMS, and eTMF to streamline operations, maintain data integrity, and support evidence-based decision-making. Passionate about the power of clinical research to drive medical advancement and improve lives, and currently seeking to contribute to a forward-thinking organization to continue driving clinical excellence while growing into leadership roles within global clinical operations.
Overview
9
9
years of professional experience
Work History
CLINICAL RESEARCH ASSOCIATE II
AK CARE STAFFING
, United States
01.2025 - Current
- Verifying that investigators and study personnel conduct research in strict compliance with protocols, GCP, and regulatory requirements to ensure patient safety and data integrity.
- Monitoring and reporting safety concerns to sponsors and IRB/IEC, ensuring timely escalation and resolution.
- Conducting on-site and remote monitoring visits independently, performing source data verification, resolving data discrepancies, and ensuring accurate completion of CRFs/eCRFs.
- Reviewing and maintaining essential regulatory documents and site files, ensuring completeness and audit-readiness.
- Overseeing investigational product accountability and confirming proper handling, storage, and documentation.
- Preparing detailed monitoring reports and maintaining clear, comprehensive records of all site communications and follow-ups.
- Supporting sites in identifying issues, implementing corrective and preventive actions, and ensuring continuous compliance for inspection readiness.
CLINICAL RESEARCH ASSOCIATE 1
AK CARE STAFFING
, United States
07.2023 - 01.2025
- Successfully set up trial sites, ensuring timely delivery and availability of all required study materials, including Investigational Medicinal Products (IMPs) and essential documents.
- Ensure that informed consent is obtained, documented, and maintained appropriately for all trial participants, in full compliance with ICH-GCP and regulatory requirements.
- Conduct site qualification, initiation, interim monitoring, and close-out visits (remotely and on-site), maintaining full protocol, ICH-GCP, and regulatory compliance throughout all phases.
- Assess site performance and provide actionable feedback to optimize study conduct; promptly escalate critical issues to the project team and support the development and execution of corrective action plans.
- Verify accuracy and completeness of clinical data through meticulous Source Data Verification (SDV).
- Conduct ongoing review of study files to ensure compliance with Good Documentation Practice (GDP) and regulatory expectations.
- Maintain expert-level knowledge of ICH-GCP, relevant regulatory guidelines, and internal SOPs to ensure high standards across all clinical operations.
- Oversee trial site close-out activities, ensuring all regulatory and study requirements are fulfilled and properly documented.
CLINICAL DATA ASSOCIATE
TIERVLEI TRIAL CENTRE
, United Kingdom
06.2021 - 05.2023
- Company Overview: United Kingdom
- Ensured accuracy, completeness, and consistency of clinical trial data by performing regular data validation and quality checks.
- Reviewed and resolved data queries in collaboration with clinical the CRA and investigators.
- Managed clinical trial data entry and maintenance within the EDC.
- Assisted in the development and review of data management plans, data validation specifications, and data review guidelines.
- Monitored data flow timelines to ensure prompt data availability for interim and final analyses.
- Participated in data cleaning and reconciliation processes, including SAE (Serious Adverse Event), lab data, and third-party vendor data.
- Collaborated with cross-functional teams including Clinical Operations, Biostatistics, and Medical Writing to support clinical study deliverables.
- Ensured compliance with GCP, ICH guidelines, and internal SOPs during all phases of data handling and reporting.
- Contributed to database lock activities, including documentation of all data management processes.
- Provide data status reports and participate in study team meetings.
- United Kingdom
BI Analyst (Global Support Operations)
ADOBE
06.2018 - 06.2020
- Partnered with the EMEA Professional Services Team to define and deliver reporting solutions aligned with strategic business needs.
- Collaborated cross-functionally with EMEA PS Regional Sales Leads to gain deep understanding of business operations, available data, KPIs, and challenges, while also managing ad hoc data requests.
- Coordinated with the License Sales Operations Team to assess existing reporting assets, recommend enhancements, and integrate secondary data sources to enrich insights.
- Delivered actionable business insights through data analysis, presenting findings and strategic recommendations to key stakeholders.
- Collected and analysed data from multiple sources including Excel, Power BI, Salesforce, Cube, and SharePoint to produce reports aligned with business goals and performance objectives.
- Maintained and continuously improved reporting tools, ensuring metrics remained relevant and impactful for decision-making.
- Utilized Power BI to extract, merge, and transform datasets from various platforms, creating dynamic dashboards to communicate insights to senior leadership.
- Identified data trends signalling shifts in service delivery or sales demand and promptly informed regional leads to support agile decision-making.
- Collaborated with other Professional Services reporting teams to align on data strategy and consistency across the organization.
- Managed stakeholder ad hoc requests and took ownership of data collection to support tailored reporting needs.
- Delivered comprehensive quarterly business reviews (QBRs) with in-depth data analysis to guide strategic planning.
Data Analyst
Virgin Trains
12.2015 - 04.2018
- Collaborate with business and IT stakeholders to formulate and assess ideas for enhancements to BI and input into prioritisation, impact analysis, estimates and scheduling.
- Extract and optimise data from disparate data sources using SQL.
- Develop Power BI dashboard.
- Acquire data from primary or secondary data sources and maintain databases/data systems.
- Create advanced SQL queries to retrieve, update, insert and delete data.
- Work closely with internal and external clients to prioritize business and information needs.
- Monitored customers experience analysis.
Education
B.Sc. - Electronics Engineering
London Metropolitan University
06.2014
National Diploma - Electronics Engineering
Bromley College of Further and HIGHER EDUCATION
01.2009
Skills
- Clinical Trial Monitoring (On-site & Remote)
- ICH-GCP
- FDA Compliance
- Protocol Development & Review
- Site Initiation
- Qualification Visits
- Interim Monitoring Visit
- Close Out Visit
- Risk-Based Monitoring
- CAPA
- Data Query Resolution
- EDC & CTMS Platforms (eg, Medidata, Veeva)
- Regulatory Documentation (eTMF, ISF)
- Patient Recruitment & Retention Strategies
- Advance Excel
- SQL
- Power BI
- Salesforce
Therapeutic Areas Of Experience
- Endocrinology (Phase 1&2)
- Neurology (Phase 2)
- Respiratory (Phase 1)
- Ophthalmology (Phase 3)
- Nephrology (Phase 2)
References
Available on request
Timeline
CLINICAL RESEARCH ASSOCIATE II
AK CARE STAFFING
01.2025 - Current
CLINICAL RESEARCH ASSOCIATE 1
AK CARE STAFFING
07.2023 - 01.2025
CLINICAL DATA ASSOCIATE
TIERVLEI TRIAL CENTRE
06.2021 - 05.2023
BI Analyst (Global Support Operations)
ADOBE
06.2018 - 06.2020
Data Analyst
Virgin Trains
12.2015 - 04.2018
B.Sc. - Electronics Engineering
London Metropolitan University
National Diploma - Electronics Engineering
Bromley College of Further and HIGHER EDUCATION
Similar Profiles
Ekene NzeremEkene Nzerem
CNA at BrightStar CareCNA at BrightStar Care
Syed Kashif AbbasSyed Kashif Abbas
Manager at AK Marketing ,AK Real Estate & BuildersManager at AK Marketing ,AK Real Estate & Builders
Sanmith LepchaSanmith Lepcha
Casual Carer and Cleaner at Yes Staffing Care Solution and Atlas CareCasual Carer and Cleaner at Yes Staffing Care Solution and Atlas Care
Gumecindo BeltranGumecindo Beltran
Estimator at Victor EnvelopeEstimator at Victor Envelope
AHEMD AFANDYAHEMD AFANDY
Owner & Sr. Android Developer (Self-Employed) at AI Study ScannerOwner & Sr. Android Developer (Self-Employed) at AI Study Scanner