Obianuju Okigbo
Houston,TX
Summary
Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to ensure the safety of the patients as well as the efficacy of the study drug to meet research objectives.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Clinical Research Associate(In House CRA Remote)
Yuma Clinical Trials
04.2022 - Current
- Summary of study involved ;phase l Dose -Escalation study of combination of Gedatolisib(a Dual Inhibitor of P13-K and mTOR) with Palbociclib and Faslodex in the Neoadjuvant Setting in previously Untreated Patients with ER+\HER2-Breast Cancer
- Conducted site evaluation for pre selection,site initiation monitoring and close out out visit for the study and to ensure compliance as to informed consent form,screening ,enrollment and randomization of study subjects according to study synopsis and protocol.
- Maintained the clinical trials management system,Electronic Data Capture and other project tracking tools.
- Ascertains and recommends appropriate follow-up response to issues at clinical sites Conducts on-site study-specific training, site facilities inspection and collection of regulatory documents Monitors site ICH-GCP compliance, patient safety, and completeness and quality of the on-site files Identifies, documents, and resolves site regulatory issues, questions, and concerns discovered during visits Generates monitoring visit reports and telephone contact reports in accordance with monitoring plan Collaborates with site staff during initiation visits on establishing site recruitment plan.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality and other s wet-ink original documents to the paper trial master file (TMF) and files copies in the electronic TMF.
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
- Processed specimens for clinical trials, sample storage and assay to provide registry of samples for test development, validation and analysis.
Clinical Trial Assistant
Yuma Clinical
02.2021 - 02.2022
- Served as primary in-house contact for Principal Investigators (PIs) and clinical site staff.
- Prepared clinical sites and CRAs for on-site visits.
- Conducted biweekly site contacts on recruitment, site staff, supplies, data entry, and patient safety.
- Generated contact reports in accordance with departmental timelines and sponsor timelines.
- Reviewed site-level data in clinical systems and ensured timely, high quality data entry compliance.
- Collected updated/amended regulatory documents in collaboration with CRA.
- Identified site issues regarding documentation, communication, and training and recommends solutions.
- Ensured timely resolution and closure of site issues, including regulatory quality control findings.
- Re-trained site staff remotely on study-specific tasks and procedures.
- Represented function at investigator meetings.
- Facilitated site access to study systems and ensured sites were compliant with safety reporting requirements.
- Collaborated with Clinical Trial Specialists and Site Contract Leads on contract, budget, and ICF negotiations.
- Prepared and collected essential regulatory documents for review and approval during site start-up.
- Provided prepared ethics committee package to sites for submission and followed up to secure approval Mentored new project and local team members and created site management tools for the project team.
Clinical Research Trial (internship)
Yuma Clinical Trials
09.2021 - 01.2022
- Reviewed,tracked and collected investigational sites record to check for compliance in screening and enrolling patients according to protocol.
- Collaborated with the Regulatory Affairs Department to review initial essential documents.
- Created regulatory document templates as well as assembled and distributed regulatory documents to sites.
- Reviewed and negotiated Informed Consent Forms (ICFs) with the sites and Sponsors.
- Assisted sites with central and local Institutional Review Board/ethics committee submissions.
- Managed TMF audits and worked with sites and CRAs to ensure files are audit-ready.
- Collected and reviewed regulatory documents for completeness and accuracy.
- Performed study drug reconciliation using accountability documentation.
- Distributed Confidential Disclosure Agreements (CDAs)/feasibility surveys and followed up accordingly.
Education
Bachelor of Arts - Biology
University of Ibadan
Oyo State2012
Skills
- MS Office(Word,Excel,Outlook,PowerPoint)
- CTMS Medidata
GCP SOPsProtocolQuality AssuranceData Entry
EDC EMReTMF SOPsALCOA
TECHNICAL SKILLS
- Agile,Adaptable &Critical Thinker
- Oncology(phase ll& lll)
- Infectious Disease(phase l,ll &lll)
- Diabetic Peripheral Neuropathy(phase l,ll &lll)
THERAPEUTIC EXPERIENCE
Certification
Certified Clinical Research Associate Professional -CRA Academy
Latinos in clinical Research
Affiliations
Member, Association of Clinical Research Professionals (2021- present)
Black women in Clinical Research BWICR (2023-present)
Timeline
Clinical Research Associate(In House CRA Remote)
Yuma Clinical Trials
04.2022 - Current
Clinical Research Trial (internship)
Yuma Clinical Trials
09.2021 - 01.2022
Clinical Trial Assistant
Yuma Clinical
02.2021 - 02.2022
Bachelor of Arts - Biology
University of Ibadan