Tosin Ola
Houston
Summary
Senior Clinical Research Associate with 10+ years of independent monitoring experience across pharmaceutical, CRO, and academic research environments. Deep expertise in Phase I–IV trials, including early-phase, high-complexity, and safety-intensive studies. Extensive therapeutic exposure in immuno-oncology, ophthalmology, dermatology, CNS, cardiovascular, respiratory, infectious diseases, metabolic disorders, and rare diseases. Known for inspection-ready documentation, strong site relationship management, and the ability to resolve complex operational issues. Highly proficient in ICH GCP, risk-based monitoring, early-phase oversight, and cross-functional collaboration. Adept in EDC, CTMS, eTMF, and clinical quality systems with a consistent record of supporting high-enrolling, high-performing sites.
Knowledgeable Clinical Research Associate with several years of experience in documenting and assisting in clinical trials research. Clear, concise and effective written communication abilities. Thorough knowledge of FDA and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed.
Motivated and methodical clinical research professional arranging sites, operations and regulatory functions. Proficient in data capture procedures and action planning. Seeking a dynamic, growth-oriented position.
Original Clinical Research Associate with exceptional analytical and communication skills. Profound knowledge of FDA regulatory requirements. Superior organizational, record retention and time management skills. Talented at designing clinical research projects and project plans.
Demonstrated skills in conducting clinical site visits and resolving issues related to participant eligibility, database protocols, or study procedures. Experience includes various types of clinical trials and studies.
Dedicated senior clinical research associate successful at evaluating sites, initiating trials and managing closeouts. Experienced with trials and successful at adapting to new processes. Bringing excellent organizational, planning and interpersonal skills gained during several-year career.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Clinical Research Associate (Contract)
Teva Pharmaceuticals
10.2025 - Current
- Conduct monitoring visits (PSV, SIV, IMV, COV) ensuring adherence to protocol, ICH GCP, and regulatory requirements.
- Perform SDR/SDV, regulatory review, and IP accountability to ensure data accuracy and integrity.
- Oversee the safety subject, informed consent, and timely reporting of safety events.
- Review ISF and Pharmacy Binder; reconcile with TMF to maintain inspection-ready documentation.
- Identify deviations, data inconsistencies, and compliance risks; escalate issues to study leadership.
- Maintain strong communication with investigators to track enrollment, KPIs, IP supply, and site performance.
- Prepare high-quality MVRs and follow-up letters within required timelines.
Senior Clinical Research Associate II
IQVIA
06.2022 - 09.2025
- Conducted qualification, initiation, interim, and close-out visits across multiple therapeutic areas.
- Ensured protocol adherence and subject safety through comprehensive SDV/SDR and regulatory review.
- Verified site staff training, delegated responsibilities, and compliance with ICF and safety reporting.
- Managed monitoring schedules and coordinated site visits to meet aggressive timelines.
- Supported ethics/regulatory submissions and contributed to audit and inspection readiness.
- Oversaw site equipment, supplies, and sample logistics.
- Authored detailed MVRs and FULs documenting site performance and corrective actions.
- Mentored junior CRAs through co-monitoring and performance feedback.
- Ensured compliance with FDA regulations, ISO standards, and GCP guidelines.
Senior Clinical Research Associate I
IQVIA
08.2018 - 06.2022
- Executed monitoring visits per Monitoring Plan requirements, ensuring protocol compliance and high-quality data.
- Participated in feasibility assessments, site selection, and qualification activities.
- Reconciled ISF with TMF to maintain accuracy and inspection readiness.
- Provided operational insights to support contract and budget discussions.
- Maintained study trackers, monitored KPIs, and ensured timely resolution of action items.
- Participated in CRA, study team, and investigator meetings.
- Performed UAT for EDC and clinical systems, documenting findings and supporting improvements.
Clinical Research Associate I/II
LabCorp
08.2014 - 06.2018
- Conducted site selection, initiation, monitoring, and close-out visits under GCP and SOP requirements.
- Performed SDV, IP accountability, and protocol compliance checks.
- Trained site personnel on documentation, CRF completion, and data entry procedures.
- Reviewed data queries, assisted with resolution, and monitored data status reports.
- Identified safety concerns, deviations, and data trends; escalated as appropriate.
- Supported feasibility assessments and site readiness activities.
Clinical Research Coordinator
Staten Island Hospital
06.2012 - 07.2014
- Served as primary liaison between PI and sponsors/CROs; coordinated regulatory submissions and IRB documentation.
- Developed study-specific training tools and educated site staff on protocol requirements.
- Screened and enrolled subjects; ensured informed consent and subject safety.
- Managed ISF documentation and maintained audit-ready regulatory files.
- Supported enrollment, retention, and study resource planning.
- Coordinated clinical trials and ensured compliance with regulatory requirements.
- Managed patient recruitment and maintained participant records throughout studies.
- Facilitated communication between researchers, sponsors, and regulatory agencies.
- Organized training sessions for staff on clinical trial processes and documentation.
- Oversaw data collection and ensured accuracy in research findings.
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Monitored patient safety during clinical trials according to established guidelines.
- Reviewed CRFs for completeness and accuracy before database entry.
Education
Bachelor of Science - Business
University of Phoenix
Tempe, AZSkills
- Site Qualification
- Initiation
- Interim Visits
- Close-Out Visits
- Source Data Review
- Source Data Verification
- Protocol Compliance
- Deviation Management
- Informed Consent Oversight
- Subject Safety
- Regulatory Documentation
- ISF Reconciliation
- TMF Reconciliation
- Risk-Based Monitoring
- Issue Escalation
- Vendor Management
- Site Relationship Management
- Monitoring Visit Reports
- Follow-Up Letters
- Early Phase Study Execution
- Training
- Mentoring
- EDC
- Medidata Rave
- Veeva Vault
- Peoplesoft
- Clindex
- Inform
- CTMS
- IL2
- Knowledge Net
- Clinical Systems
- ETMF
- ECRF
- UAT Testing
- Documentation
- TMF Management
- Regulatory Files
- Compliance
- ICH GCP
- CFR
- SOP Adherence
- Microsoft Office Suite
- Conducting monitoring visits
- Protocol adherence
- Regulatory compliance
- Safety reporting
- Site selection coordination
- Audit readiness preparation
- Educating site personnel
- Effective communication
- Attention to detail
- Time management
- Mentoring junior staff
- Quality control
- Team Training
- Report writing
Certification
ACRP-CP
Therapeutic Experience
- Ophthalmology: Early-phase studies, medical devices, visual acuity
- Dermatology: Atopic Dermatitis, Fillers, Vitiligo
- Oncology: Solid Tumor, Lung, Ovarian
- Medical Devices: Hernia Mesh, Pacemaker, Prosthetic Valves, Pain Devices, IVDR, Vacutainer
- Infectious Diseases: Hepatitis A, COVID-19, HIV
- CNS: Stroke, Parkinson’s, Bipolar, Schizophrenia, MS, Alzheimer’s
- Cardiovascular: Heart Failure, MI
- Metabolic: Obesity, Diabetes
- Respiratory: Asthma, Pulmonary Disease
- Rare Diseases: Amyloidosis
Timeline
Clinical Research Associate (Contract)
Teva Pharmaceuticals
10.2025 - Current
Senior Clinical Research Associate II
IQVIA
06.2022 - 09.2025
Senior Clinical Research Associate I
IQVIA
08.2018 - 06.2022
Clinical Research Associate I/II
LabCorp
08.2014 - 06.2018
Clinical Research Coordinator
Staten Island Hospital
06.2012 - 07.2014
Bachelor of Science - Business
University of Phoenix