Ade Kelani Email & Phone Number

• Traveling CRA, successfully managing day-to-day activities of assigned early and late phase Oncology clinical trials, exceeding study metrics and completion goals, including trip report submissions.• Monitored investigator sites with a risk-based monitoring approach: applied root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failure and corrective/preventive actions to bring the site into compliance and decrease risks.• Documented observations in reports and letters promptly. Escalated observed deficiencies and issues to clinical management expeditiously and followed all issues through to resolution.• Facilitated study-related document development, including ICF templates, TMF plans, and essential document lists, ensuring site audit readiness.• Spearheaded site communication and maintenance deliverables to meet timelines.• Provided coaching and training to junior CRAs, fostering their professional development and team success.• Conducted site initiation visits and monitoring visits, training site personnel, identifying potential issues, and ensuring protocol adherence.• Assessed data documentation, reports, and records for accuracy and consistency with CRF and study objectives.• Provided oversight and insights into trial activities (compliance, enrollment, data quality) to PIs, study sponsors, and leadership teams.

• Successfully led the initiation, planning, and execution of 10+ early and late-phase clinical studies, maintaining 100% compliance with SOPs, FDA regulations, and ICH/GCP guidelines. Ensured site audit readiness.• Developed and maintained essential study documents and trackers, enhancing efficiency in site and study management activities.• Provided comprehensive oversight of contract vendors and CRO activities, ensuring compliance with study plans, SOPs, and regulatory guidelines.• Collaborated with the Associate Director to develop clinical monitoring plans, conducting • Proactively identified and escalated study-related issues, participating in problem-solving and risk mitigation strategies.

• Successfully led the initiation, planning, execution, maintenance, and close-out of 6 clinical studies, ensuring adherence to timelines and budget, resulting in a 95% on-time completion rate and staying within budget constraints by an average of 10%.• Developed and maintained essential study documents and trackers, leading to a 30% improvement in efficiency in site and study management activities.• Conducted on-site and remote monitoring activities, ensuring data accuracy through Source Data Review (SDR), Source Data Verification (SDV), and CRF review.• Conducted qualification, initiation, monitoring, and closeout visits for research sites, ensuring compliance with approved protocols.• Maintained effective communication with medical site staff, including coordinators and clinical research physicians, to facilitate smooth study operations.