Zelo Selbor
Houston,TX
Summary
Dynamic Senior Clinical Research Associate with extensive oncology and cell therapy expertise at Bristol Myers Squibb. Proven track record in ensuring patient safety and data integrity while leading cross-functional teams. Skilled in risk-based monitoring and compliance, with a strong focus on mentorship and continuous improvement in clinical operations.
Overview
9
9
years of professional experience
Work History
Senior Clinical Research Associate
Bristol Myers Squibb
Houston, TX
05.2023 - Current
- Oversaw multiple oncology Phase II/III sites including CAR-T therapy for hematologic malignancies, ensuring patient safety and data accuracy.
- Supported FDA inspection readiness and tracked GCP deviations and CAPAs.
- Conducted risk assessments and ensured compliance with SOPs and regulatory requirements.
- Facilitated cross-functional meetings with medical monitors, statisticians, and vendors.
- Led on-site and remote monitoring visits ensuring protocol adherence and real-time issue resolution.
- Collaborated with clinical operations and data management teams to ensure data quality and timely database locks.
- Mentored junior CRAs and provided oversight of their monitoring deliverables in alignment with SOPs and timelines.
Clinical Research Associate II
Genentech
Remote
06.2021 - 05.2023
- Company Overview: via CRO partnership
- Monitored oncology and CNS trials (breast, ovarian, Alzheimer’s) across U.S. sites.
- Ensured informed consent accuracy and protocol compliance; escalated safety concerns appropriately.
- Trained new site staff and CRAs on sponsor expectations and technology platforms.
- Managed TMF accuracy, query resolution, and trial master data reporting.
- Worked cross-functionally to support protocol amendments and implemented updates at site level swiftly and accurately.
- Conducted site risk assessments and initiated Corrective and Preventive Actions (CAPAs) to improve site performance.
- Reviewed and reconciled regulatory binders to ensure continuous inspection readiness.
- Via CRO partnership
Clinical Research Associate I
Syneos Health
Houston, TX
01.2018 - 05.2021
- Executed monitoring visits for solid tumor and rare disease studies, ensuring alignment with sponsor protocol and FDA guidelines.
- Verified AE/SAE reports and facilitated resolution of data discrepancies.
- Supported CRA team during protocol amendments, informed consent updates, and database lock.
- Led site training during SIVs and maintained real-time tracking via CTMS.
- Tracked subject visit schedules and ensured protocol-required assessments were conducted on time.
- Provided real-time support to investigative site personnel on GCP and protocol interpretation queries.
- Assisted in feasibility and site selection process by evaluating site capabilities and recruitment strategies.
Clinical Research Coordinator
Texas Clinical Research Institute
Houston, TX
09.2016 - 12.2017
- Managed early-phase medical device and pharma studies, including IVD and catheter-based cardiac products.
- Maintained AE logs, regulatory binders, and laboratory data.
- Participated in site audits and developed CRA-readiness tools, supporting cross-functional alignment.
- Scheduled and coordinated patient visits in alignment with protocol timelines and visit windows.
- Liaised with sponsors and monitors to support source data verification and resolve open queries efficiently.
- Ensured lab kits, study drugs, and supplies were properly managed and documented according to protocol.
Education
B.Sc. - Microbiology
Olabisi Onabanjo University
Skills
- ICH-GCP
- FDA
- GMP/GDP Compliance
- Oncology & Cell Therapy Experience
- Site Monitoring
- Electronic TMF
- CTMS
- EDC Systems
- Risk-Based Monitoring
- Vendor and CRO Oversight
- Clinical Documentation
- Query Resolution
- Patient Safety
- Protocol Adherence
Therapeutic Areas
- Oncology: Solid Tumors, Breast, Ovarian, Non-Hodgkin Lymphoma (CAR-T)
- CNS: Alzheimer’s, Cerebral Palsy, Multiple Sclerosis, Pain
- Rare Diseases: DMD, CF, Epidermolysis Bullosa
- Devices/IVDs: Atrial Fibrillation Devices, Cardiac Rhythm Monitors, Diagnostic Kits
Timeline
Senior Clinical Research Associate
Bristol Myers Squibb
05.2023 - Current
Clinical Research Associate II
Genentech
06.2021 - 05.2023
Clinical Research Associate I
Syneos Health
01.2018 - 05.2021
Clinical Research Coordinator
Texas Clinical Research Institute
09.2016 - 12.2017
B.Sc. - Microbiology
Olabisi Onabanjo University
Similar Profiles
Siddharth SinghSiddharth Singh
Pharmaceutical Manufacturing Operator at Bristol Myers SquibbPharmaceutical Manufacturing Operator at Bristol Myers Squibb
Bria SpurlinBria Spurlin
QC Scientist at Bristol Myers SquibbQC Scientist at Bristol Myers Squibb
Eric J. HealyEric J. Healy
Operator 2 at Bristol Myers SquibbOperator 2 at Bristol Myers Squibb
GUSTAVO BRIONESGUSTAVO BRIONES
MATERIALS MANAGEMENT PLANNER at Bristol-Myers SquibbMATERIALS MANAGEMENT PLANNER at Bristol-Myers Squibb
Lilyana PerezLilyana Perez
Foreman at SK ElectricForeman at SK Electric