Eve Atinwo

Managed vendor and CRO activities, ensuring compliance with contracts, protocols, and regulations. Coordinated with CRAs, managed resources, and liaised with CROs, effectively handling escalations and ensuring clear expectations. Oversaw day-to-day trial operations, resolved audit issues, managed clinical trial vendors, and controlled project budgets and timelines.

Provided direction and leadership to multiple clinical operations project teams, managing deliverables from site start-up to database lock. Oversaw operational management of CRAs and CTAs, ensured SOP implementation, and supported external vendors and clinical sites. Drove inspection readiness through meticulous eTMF maintenance and assisted with regulatory submissions and audit preparation.

Implemented and monitored clinical trials, ensuring compliance with GCP guidelines and applicable regulatory requirements. Conducted comprehensive site monitoring visits, including qualification, initiation, data review, and close-out activities. Managed site file reconciliation, source document verification, CRF and query resolution, drug accountability, and SAE reporting.

Participated in pre-study and initiation meetings, ensuring complete understanding of study objectives and data requirements. Assisted in site identification, feasibility assessments, and training, performing pre-study visits and providing site selection recommendations. Monitored clinical sites to ensure adherence to protocol and safety requirements, managed data accuracy and completeness in CRFs

Supported site identification, recruitment, and qualification, performing study tracking and managing essential documents from collection to close-out. Ensured compliance with applicable regulations, ICH/GCP guidelines, and SOPs throughout the document lifecycle. Provided general support to CRAs, assisted with site and data query resolution, and managed IRB submissions and site changes.

Assisted Clinical Team Leads and CRAs with updating and maintaining clinical systems to track site compliance and performance. Supported the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to scope and SOPs. Assisted with tracking and management of CRFs, queries, and clinical data flow, serving as a central contact for project communicatio

Ensured site start-up deliverables were met, providing accurate projections, reports, and updates. Conducted ongoing risk assessments and evaluated strategies to mitigate potential deficiencies in clinical timelines, costs, and quality.

Entered data into the EDC system and resolved queries for assigned studies. Coordinated meetings with internal and external stakeholders and participated in ongoing training related to the proper conduct of research.