KIKE IGBINOBARO
Austin,TX
Summary
Results-driven Clinical Research Associate with 5 years of Experience with proven track record of successfully managing diverse clinical trials across various therapeutic areas, including Women's Health, Nephrology, Dermatology, Ophthalmology, Respiratory, CNS, Rheumatology, Cardiology, Endocrinology, Oncology and Infectious Diseases. Phase II-IV study expertise with a strong foundation in site monitoring, ensuring compliance with regulatory requirements and GCP guidelines. Well-versed in coordinating operations and conducting all kinds of monitoring visits, including PSVs,SIVs, IMVs and COVs, both remotely and Onsite. Knowledgeable about action planning, database locking and standard operating procedures.
Overview
14
14
years of professional experience
Work History
Clinical Research Associate I
Concentric Clinical Research
03.2019 - Current
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
- Demonstrates diligence in protecting the confidentiality of each subject/patient
- Assesses 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
- Perform source data verification and follow up on data queries at the site level, on-going review of any Risk Based Monitoring related information influencing data quality and frequency of site visits
- Ensure accurate and timely reporting and follow up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations
- Perform investigational product (IP) inventory, reconciliation and reviews storage and security
- Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
- Verifies issues or risks associated with blinded or randomized information related to IP
- Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re) labeled, imported and released/returned
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Escalate quality issues as appropriate
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
- May support start-up phase
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
- Collaborate and liaise with study team members for project execution support as appropriate.
Study Start-Up Coordinator
Concentric Clinical Research
10.2015 - 03.2019
- Communicated with research sites (doctor's offices, universities, hospitals, etc.)
- Performed start up and site activation activities according to applicable regulations, SOPs and work instructions
- Distribute completed documents to sites and internal project team members
- Collected all essential documents required before the site begins to screen patients to participate in the clinical trial
- Reviewed, tracked and followed up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines
- Maintained and performed ongoing quality review of trial documents within the Trial Master File (TMF)
- Collected, reviewed, organized, and assembled regulatory start-up submissions (includes submissions to Institutional Review Boards)
- Maintained timelines for study start-up through internal team collaboration
- Completed independent learning modules, interactive exercises, and team workshops through the core curriculum
- Gained exposure to real-world tasks through a robust mentoring program
- Joined other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.
Clinical Research Regulatory Specialist
Diabetes & Endocrine Clinic
08.2010 - 10.2015
- Prepared, facilitated and coordinated the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy
- Ensured that all documents are complete and that the submission packet meets the IRB's revision submission requirements prior to sending to the IRB
- Follows-up, communicates and facilitates responses to queries of the IRB, Sponsor and other committees as a result of their review of submissions
- Coordinated the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state and local agencies governing biomedical research
- Obtains Sponsor approval of consent form prior to submission to the IRB
- Facilitated and coordinated the timely and accurate submission of regulatory documents (hard copies and electronic binders) and IRB submissions by collaborating with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents
- Worked with study team to develop working knowledge of all ongoing studies and effectively communicates and design and inclusion criteria of these studies' potential participants
- Ensured that regulatory binders are audited and maintained
- Tracks workload and status of pending protocols and associated supporting documents in order to provide efficient customer service to the Research team
- Participates in quality assurance (QA) and control programs related to overall project and patient data, as needed
- Oversaw QA initiatives for the department to support research staff and leaders during sponsor and FDA audits
- Facilitates investigator-initiated research by ensuring all regulatory requirements are met, to include ensuring requirements for trial registration, results and reporting are completed in a timely manner consistent with federal regulations
- Assured confidentiality of paperwork, documents, and calls
- Maintained timely communication with patients.
Education
Associate of Science - Biology (Nursing Specialization)
Houston Community College
05.2023
Bachelor of Science - Public Administration
Ambrose Alli University
2007
Skills
- Knowledge:
- Ability to demonstrate full working knowledge of standard concepts, practices, procedures
- FDA Regulations, ICH GCP Guidelines, HIPPA and policies with ability to use them in varied situations
- Knowledgeable in Electronic Data Capture (EDC) systems, such as, InForm, Medidata Rave, DataLabs, CTMS; eClinical and eTMF; Veeva Vault
- Microsoft Word, Microsoft Access, Microsoft Excel, Microsoft Power Point
- Personal: Leadership skills,
- written and communication skills, ability to learn fast and solve problem
- Site Management
- Detailed documentation
- Coordinating site operations
- Informed Consent Process
- Site monitoring
- Drug Accountability
Timeline
Clinical Research Associate I
Concentric Clinical Research
03.2019 - Current
Study Start-Up Coordinator
Concentric Clinical Research
10.2015 - 03.2019
Clinical Research Regulatory Specialist
Diabetes & Endocrine Clinic
08.2010 - 10.2015
Associate of Science - Biology (Nursing Specialization)
Houston Community College
Bachelor of Science - Public Administration
Ambrose Alli University
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