Chima Alakwe

Experience

1. Senior Clinical Research Associate

   AbbVie

   Jan 2020 — Present · Houston, TX, US

   Interacts with personnel from study Sponsors, investigational sites, vendors, and functional groups to enable quality and on-time execution of clinical trials.Identifies potential sites for participation in clinical trials.Performs protocol/site feasibility and Pre-Study Visits to recommend qualified sites.Participates in Investigator Meetings, CRA and Study Coordinator training sessions, and assists sites with study-related questions as needed.Provides feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed.Performs Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan.Submits quality and on-time Monitoring Visit Reports and follows-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS).Reviews Investigator Site Files (ISFs) to ensure essential documents are current and submitted to the Trial Master File (TMF) throughout the trial for ISF/TMF reconciliation purposes.Ensures sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed. ISF/TMF must be always maintained in an inspection ready state.Establishes regular lines of communication and administers ongoing protocol/study-related training to assigned sites. Assists with site management tasks and ensure continuous data flow (i.e, on-time site data entry, query resolution, and source document verification). Assess the clinical research site\'s patient recruitment/retention success and offer suggestions for improvement.Ensures proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial supplies.Prepares sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations.