Lawrence Ibelegbu
Houston,TX
Summary
Experienced in managing clinical trials and monitoring patient safety and treatment efficacy, bringing 8 years of research experience as a Senior Clinical Research Associate. Expertise lies in conducting trials related to respiratory, mental and neurological health conditions, including COPD, depression, attention disorders, Alzheimer's, and sleep-related issues. Strong knowledge of clinical regulations and a passion for improving patient outcomes through research and innovation. Dedicated to ensuring the highest standards of quality and compliance. Proficient in the use of EDC, IVRS, TMF, and CTMS systems, as well as sound knowledge of Good Clinical Practices (ICH-GCP) and FDA regulations. Able to navigate complex processes with ease. Proficient in MS Suites (Word, Outlook, PowerPoint, Publisher, Project, and Access) for effective communication and presentation of findings. Known for hardworking nature, organizational skills, and attention to detail. Excel in performing all phases of clinical research trials.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
AstraZeneca Pharmaceuticals LP
09.2022 - 10.2024
- Conducted clinical trials in accordance with study protocol.
- Traveled to investigative sites to conduct site qualification (PSSV/SQV), initiation (SIV), interim monitoring (IMV) and close-out visits (COV) in compliance with AstraZeneca's Procedural Documents.
- Conducted regular site visits to ensure protocol adherence and provided training, support, and advise to investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
- Confirmed site staff has completed and documented the required training appropriately including ICH-GCP training, prior to and for the duration of the study.
- Routinely performed site document reviews to ensure protocol adherence and compliance with applicable regulations and standards (e.g., GCP/ISO, IRB/EC policies and procedures).
- Performed Source Data Review (SDR), Source Data Verification (SDV), Case Report Form (CRF) review, Remote Data Checks (RDC) in accordance with the monitoring plan.
- Reviewed/reported AE/SAEs and protocol deviations per industry and AstraZeneca's standards.
- Maintained all project supporting systems, with data from study sites as per required timelines e.g. CTMS, EDC, eTMF, etc.
- Performed regular Site Quality Risk Assessment and adapted monitoring intensity accordingly during the study.
- Shared information on patient recruitment and study site progress (site quality/performance) within the LST.
- Ensured compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health, and environment).
- Ensured sites maintained an acceptable inventory of clinical supplies and associated documentation.
- Furnished proficient and timely documentation of monitoring activities/visits (e.g., complete trip reports, contact records) and maintained compliance with Astrazeneca's business travel and expense policies.
Clinical Research Associate
Premier Research
03.2019 - 09.2022
- Managed and monitored clinical trials focused on mental health conditions like Major Depressive Disorder (MDD) and Attention Deficit Disorder (ADD).
- Worked closely with researchers on Alzheimer’s disease trials, aimed at finding new treatments for memory loss and cognitive decline.
- Supported trials on hypersomnia, a condition where patients experience excessive daytime sleepiness, helping to assess treatment outcomes.
- Ensured trial site(s) follow the study protocol, GCP, SOPs, and applicable regulatory requirements.
- Conducted source data review/verification according to the monitoring plan.
- Verified proper subject informed consent process took place and appropriate documentation was collected.
- Verified eligibility for enrolled subjects.
- Regularly reviewed maintenance of required documentation in the Investigator File and/or Regulatory Binder.
- Reviewed data entry progress and worked with the site to ensure compliance with timelines.
- Responsible for training of site staff and communicating directly with investigative sites to provide study directions, answer questions, assess recruitment rates, and respond to sponsor requests.
- Performed and documented pre-study site evaluations, site initiations, regulatory document collection, interim monitoring, and study close-out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, Organizational SOPs, applicable regulatory requirements, and defined quality and performance standards.
Clinical Research Associate
Premier Research
11.2018 - 03.2019
- Ensured compliance with the trial conduct with the protocol and the applicable guidelines and regulations.
- Reported any findings related to the study to the Project Managers responsible for the respective studies.
- Reviewed patient documents (informed consent, subject information sheet), clinical study protocol, CRF, and trial-related financial agreements as required to ensure compliance with the protocol and study guidelines.
- Ensured that Serious Adverse Events, IND Safety Alerts, Protocol Deviations, and other safety-related items were reported to the IRB to ensure that the subject's rights, safety, and well-being are protected.
- Ensured study staff conducting the protocol received the proper materials, instructions, and training to safely enter subjects into the study and complete the protocol requirements.
- Performed PSSV, SIV, IMV and COVs.
- Verified data integrity and accuracy.
- Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review and monitoring for missing or implausible data.
- Participated in the development and review of departmental SOPs and processes.
- Assisted in the review of study documents for accuracy and completeness.
Clinical Research Coordinator
Md Anderson Cancer Centre
01.2016 - 11.2018
- Coordinated the day-to-day activities of the research study team specifically engaged in carrying out the research clinical protocol.
- Coordinated and actively recruited and formally consents study subjects for enrollment.
- Prepared research study advertisements for submission to the institutional review board (IRB) for approval to aid in subject recruitment.
- Performed input, retrieval, and analysis of data for processing and validation, and maintained research databases on excel.
- Managed calendars and conducted telephone, face-to-face interviews, or send emails for follow-up visits as per protocol to administer assessment data collection instruments.
- Organized and facilitated meetings, conferences, and other events associated with research activities.
- Documented all correspondence and communication pertinent to the research and responded to study site monitoring visit findings and, after consultation with pi, implements approved recommendations.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Ensured the safety and well-being of patients.
Education
Bachelor Of Science - Public Health
IMO STATE UNIVERSITY
Skills
- Clinical trial management
- Site Management & Monitoring
- Detailed documentation
- Pharmacovigilance
- ICH guidelines
- GCP auditing
- Informed Consent Process
- Communication
- Critical & Analytical thinking
- Decision-making & Problem-solving
- Organizational skills
- Multi-tasking
Certification
- GCP- ICH, 06/01/25
- CPR, 07/01/25
Software experience
Medidata Rave, Inform, RAVE CTMS, Oracle eClinical, Veeva Vault, Oracle, Florence, IQVIA, Signant Health, Clinphone, IMPALA, Smartsheet, Jira, Azure DevOps, One Note, MS Project, Adobe Pro
Therapeutic knowledge
COPD, Cerebral Palsy, Pain, Parkinson’s disease, Bipolar Disorder, Schizophrenia, Hip Prosthesis, Vascular Graft, Heart Valves, Pediatrics, Pacemakers, Catheters, IVD, Hypertension, Heart Failure, Cardiomyopathy, ACS, Coronary Artery Disease, HPV (Vaccine), Diabetes, Gout, Cystic Fibrosis
Timeline
Clinical Research Associate
AstraZeneca Pharmaceuticals LP
09.2022 - 10.2024
Clinical Research Associate
Premier Research
03.2019 - 09.2022
Clinical Research Associate
Premier Research
11.2018 - 03.2019
Clinical Research Coordinator
Md Anderson Cancer Centre
01.2016 - 11.2018
Bachelor Of Science - Public Health
IMO STATE UNIVERSITY