Isa elegbede
Richmond,Texas
Summary
Clinical Research Associate with expertise in managing global Phase III clinical trials across various therapeutic areas and indications. Extensive experience in site initiation, patient recruitment, monitoring, and study close-out, ensuring adherence to ICH-GCP, FDA, and international regulatory requirements.
Overview
16
16
years of professional experience
Work History
CLINICAL RESEARCH ASSOCIATE II
IQVIA
07.2018 - Current
- Conduct Site Visits (SIV, IMV, COV): Perform site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs) to assess site readiness, monitor progress, and ensure proper closure procedures, including documentation review and IP reconciliation.
- Mentor and Train Junior CRAs and Site Staff: Provide guidance and training to junior CRAs, study coordinators, and site staff on study protocols, data collection standards, and regulatory compliance, fostering a high level of site performance.
- Protocol and CRF Development and Review: Collaborate with clinical trial teams to develop, review, and refine study protocols, Case Report Forms (CRFs), and other essential study documents to ensure accurate data capture and adherence to trial objectives.
- Site Relationship Management: Build and maintain strong relationships with site investigators, study coordinators, and key stakeholders to facilitate effective communication, problem-solving, and long-term collaboration.
- Patient Recruitment and Retention Oversight: Work closely with clinical sites to develop and implement patient recruitment strategies, track progress, and resolve barriers to ensure enrollment targets are met on schedule.
- Data Quality Control and Source Data Verification (SDV): Verify the accuracy, completeness, and consistency of clinical trial data through detailed source data verification, identifying discrepancies and ensuring timely resolution.
- Issue Identification and Resolution: Identify, document, and resolve site-related issues, including deviations from protocol, non-compliance, or operational inefficiencies, while ensuring corrective action plans are effectively implemented.
- Regulatory Documentation Management: Prepare and oversee the submission of essential regulatory documents, including informed consent forms, safety reports, and ethics committee approvals, to ensure compliance with both local and international regulations.
- Adverse Event (AE) and Serious Adverse Event (SAE) Monitoring: Track, document, and report adverse events (AEs) and serious adverse events (SAEs) in a timely and accurate manner to sponsors and regulatory authorities, ensuring appropriate follow-up and safety assessments.
- Risk-Based Monitoring and Mitigation: Conduct site risk assessments, develop and implement risk mitigation strategies, and adjust monitoring plans based on ongoing trial data, trends, and emerging site performance risks.
CLINICAL SITE MANAGER
PPD
08.2015 - 07.2018
- Performed Site Management and Monitoring: Acted as the primary point of contact for assigned sites, providing ongoing site management, including data verification, issue resolution, and site performance tracking.
- Conducted Data Collection and Source Data Verification (SDV): Verified that all data collected at the clinical sites was accurate, complete, and consistent with the source documents, addressing any discrepancies as needed.
- Ensured Informed Consent Compliance: Verified that informed consent was obtained according to regulations and protocol requirements, ensuring that patients were properly informed before participation.
- Reported and Documented Adverse Events (AEs) and Serious Adverse Events (SAEs): Tracked, documented, and reported all adverse events, especially serious adverse events, to the sponsor and regulatory bodies, ensuring timely reporting and follow-up.
- Provided Site Training on Protocols and Systems: Delivered ongoing training to site staff on protocol updates, electronic data capture (EDC) systems, and other clinical trial processes to ensure proper execution.
- Tracked Patient Enrollment and Retention: Monitored patient recruitment and retention progress, worked with sites to overcome recruitment challenges, and ensured enrollment targets were met.
- Reviewed and Approved Case Report Forms (CRFs): Ensured the accurate completion of Case Report Forms (CRFs) by site staff, identifying and resolving any discrepancies in the data.
- Conducted Site Close-Out Visits (COVs): Ensured that study sites were properly closed at the end of the trial, reviewing all documentation, investigational products, and ensuring the resolution of outstanding issues.
CLINICAL RESEARCH ASSOCIATE I
ASTRAZENECA
06.2012 - 08.2015
- Assisted in Site Selection and Qualification Visits: Supported senior CRAs in identifying and assessing potential clinical trial sites, ensuring they had the capabilities to conduct the study.
- Supported Site Initiation Visits (SIVs): Helped in preparing and organizing site initiation visits by ensuring study materials and training documents were ready for site personnel.
- Assisted with Protocol and Regulatory Compliance: Ensured that study sites adhered to the clinical trial protocol, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.
- Performed Routine Site Monitoring Visits: Conducted regular monitoring visits to ensure accurate data collection, proper patient consent, and adherence to the trial protocol at study sites.
- Verified Data and Collection: Verified the accuracy and completeness of clinical data collected by site personnel, comparing source documents with case report forms (CRFs).
- Ensured Proper Informed Consent Procedures: Confirmed that patients were appropriately consented before their participation in the trial, ensuring that consent forms were signed and properly documented.
- Tracked Site Performance Metrics: Monitored patient enrollment, recruitment rates, and retention, working with sites to address any challenges to meet enrollment targets.
- Assisted in the Reporting of Adverse Events (AEs): Ensured timely reporting and documentation of adverse events and serious adverse events (SAEs) in accordance with regulatory requirements and sponsor protocols.
- Monitored Investigational Product (IP) Accountability: Verified proper storage, handling, and administration of investigational products at study sites, ensuring IP accountability was maintained.
CLINICAL RESEARCH COORDINATOR
MOFFIT CANCER CENTER
05.2010 - 06.2012
- Managed Study Participant Recruitment: Coordinated the recruitment, screening, and enrollment of participants for clinical trials, ensuring eligibility criteria were met.
- Administered Informed Consent: Obtained and documented informed consent from study participants, ensuring they fully understood the risks and benefits of the study.
- Ensured Protocol Adherence: Ensured that the study was conducted according to the approved protocol, Good Clinical Practice (GCP) guidelines, and regulatory requirements.
- Coordinated Study Visits: Scheduled and organized participant study visits, ensuring that all study procedures, assessments, and follow-ups were completed according to the study timeline.
- Collected and Documented Data: Gathered study data from participants through interviews, physical exams, and other required procedures. Ensured that data was accurately recorded in case report forms (CRFs) or electronic data capture (EDC) systems.
- Monitored Participant Safety: Tracked participant health and monitored for adverse events (AEs) or serious adverse events (SAEs), ensuring they were properly documented and reported.
- Maintained Study Regulatory Documents: Ensured that essential regulatory documents, such as IRB approvals, informed consent forms, and study protocols, were up to date and organized in the regulatory binder.
Education
Doctor of Philosophy (PhD) - Environmental services
Brandenburg University of Technology
Master of Science (MSc) - Environmental services and Health science
Brandenburg University of Technology
Skills
- Expert in Electronic Data Capture (EDC) systems, eTMF, and Interactive Response Technology (IRT) platforms
- Advanced proficiency in Clinical Trial Management Systems (CTMS) for seamless trial coordination and oversight
- In-depth understanding of ICH-GCP guidelines, FDA regulations, and EU directives for global compliance
- Extensive experience in designing and reviewing Case Report Forms (CRFs) to ensure accurate data collection
- Comprehensive monitoring expertise across all trial phases (I-IV), ensuring protocol adherence and data integrity
- Skilled in risk-based monitoring and implementation of corrective action plans for clinical sites
- Proficiency with MS word, PowerPoint and Excel
Timeline
CLINICAL RESEARCH ASSOCIATE II
IQVIA
07.2018 - Current
CLINICAL SITE MANAGER
PPD
08.2015 - 07.2018
CLINICAL RESEARCH ASSOCIATE I
ASTRAZENECA
06.2012 - 08.2015
CLINICAL RESEARCH COORDINATOR
MOFFIT CANCER CENTER
05.2010 - 06.2012
Master of Science (MSc) - Environmental services and Health science
Brandenburg University of Technology
Doctor of Philosophy (PhD) - Environmental services
Brandenburg University of Technology
THERAPEUTIC FOCUS
- Rare Disease: Amyloidosis, Fabry Disease, Pompe Disease, Spinal Muscular Atrophy, Duchenne Muscular Dystrophy
- Oncology: Breast Cancer, Prostate Cancer, Lung Cancer, Pancreatic Cancer, Melanoma
- Medical Device: Cardiac stents, Defibrillators, Orthopedic implants, Continuous glucose monitors (CGMs), Surgical robots, Hearing aids
- Central Nervous System: Multiple Sclerosis, Alzheimer's Disease, Parkinson's Disease, Depression, Epilepsy, Schizophrenia
- Respiratory: Chronic Obstructive Pulmonary Disease (COPD), Asthma, Pulmonary Fibrosis, Cystic Fibrosis
- Dermatology: Atopic Dermatitis, Psoriasis, Acne, Vitiligo, Hidradenitis Suppurativa
SPONSORS
Novartis, Eli Lilly, Gilead Sciences, AstraZeneca, Amgen, Surface Ophthalmic, Sanofi, Pfizer