ENIOLA BABAJIDE

• Managed 4+ Phase II-IV oncology trials (breast and ovarian cancer) with >50 active patients under strict adherence to ICH-GCP, EU-CTR and local SOPs

• Ensured 98%+ data quality in eCRF documentation through timely entry and proactive query resolution with monitors

• Served as primary liaison between study participants, principal investigators and CRO monitors to communicate protocol updates, safety reports and site status

• Prepared site for monitoring visits and support Source Document Verification through organized essential document management

• Managed investigational product accountability and document dispensing, return and disposal in accordance with temperature/storage protocols

• Assisted in >20 informed consent processes and reconsent process, ensuring all documents are signed correctly according to GCP.

• Coordinated multi-site diagnostic tuberculosis trial across 3 study centers with average 5 patient recruitments per day over 4 months

• Developed and implemented Standard Operating Procedures (SOPs) for sample processing, storage and shipping – critical experience for CRA site qualification visits

• Created Investigator Site Files (ISFs) for multiple study centers per regulatory requirements

• Performed protocol-compliant blood draws, sample processing (centrifugation) and eCRF documentation with zero protocol deviations

• Supported a yellow fever clinical study with focus on monitoring the biomarkers after the yellow fever vaccine

• Managed 2 Phase III trials, 1 Phase IV trial and 1 observational study in breast cancer with >80 participants

• Documented medical history, vital signs, laboratory results and concomitant medications in eCRF per source data

• Monitored and reported Adverse Events (AEs) and Serious Adverse Events (SAEs) within 24 hours to sponsor and ethics committee

• Conducted protocol-compliant follow-up phone calls to assess patient compliance and current health status

• Successfully completed GCP certification (IOMEDIO, 2023)

• Telephone triage of patients with symptom assessment and referral to appropriate medical facilities
• Counselled COVID-19 patients with focus on safety monitoring during quarantine (analogous to AE follow-ups in clinical trials)

• Managed care for up to 6 critically ill patients per shift with focus on vital monitoring and clinical observation

• Detailed medical documentation and communication with multidisciplinary teams – foundation for clinical trial coordination