Francisca Chikaodili Diala

Supports the Clinical Operations team in the planning, execution, management and surveillance of clinical trials and the Program Team for operational deliverables and the implementation of the clinical development strategy for a project/program. Maintaining the Trial Master File (TMF), inspections of the study documents for completeness, accuracy and compliance and SOPs and regulatory requirements. Also prepare all the oversight. Compilation of the document packages for medication release at study centers, by ensuring the completeness, correctness and that receipt, as well as carried out timeliness. Receipt of central and the country- specific study documents of clinical teams, countries and / or CROs. Collection and verification of the results of study documents for completeness, accuracy and compliance with SOPs and regulatory requirements, support in obtaining the medication released. Familiar with IRB terminology, approvals, FDA regulations, and Clinical monitoring process in accordance with GCP/ ICH Guidelines SOPs and study protocols. Following up with module inquiries and initiating solutions. Supports the team to ensure high quality study budget planning, budget management, invoice processing, and oversight.

2018, TMF conference presenter

Creating and maintaining the Trial Master File (TMF), inspections of the study documents for completeness, accuracy and compliance and SOPs and regulatory requirements. Compilation of the document packages for medication release at study centers, by Ensuring the completeness, correctness and that receipt, as well as carried out timely. Receipt of central and the country- specific study documents of clinical teams, countries and / or CROs. Collection and verification of the results of study documents for completeness, accuracy and compliance with SOPs and regulatory requirements, support in obtaining the medication released. Familiar with IRB terminology, approvals, FDA regulations, and Clinical monitoring process in accordance with GCP/ ICH Guidelines SOPs and study protocols. Following up with module inquiries and initiating solutions. Make sure that the center documents are updated as necessary and manage and maintenance Study documents. Reporting of document status and communicate issues / problems to the clinical team (CSL / CRA), Tracking of documents and regular alignment with the documents, Care of the documents in auditor- and achievable state Gathering the Investigator Participation and preparation for regulatory audits and QA as well as Inspection Readiness. Therapeutic experience includes: Oncology Phase I- 1V Clinical Drug Trial Experience in Abbvie Biopharmaceutical Germany.

Monitor Collected reviewed monitoring Reports Assists with safety Reporting and maintain tracking document Track CRFs and communicate any discrepancies / queries with CRAs and site. Performed study start-up for sites by collecting valuable documents and updating start-up supplies, site visits to determine protocol, Edit, review and maintain team travel calendars to reflect changes and routinely post to client and team members. Familiar with IRB terminology, approvals, FDA regulations, and Clinical monitoring process in accordance with GCP/ICH Guidelines SOPs and study protocols. Following up with module inquiries and initiating solutions. Liaison between client databases (CPMS Remote Patient), helpdesk and team. Report and track Serious Adverse Event / AEs and Progress on Regulatory Document collection.

Laboratory Project Image processing in cell tracking force: (Image Modeling) with Mat-lab and Image j; Particle tracking strategy to determine cellular traction force.

Project Radiology Image processing with Mat- Lab

Laboratory work

cell cultures: Glioblastoma cells histological sections, staining for Elastic fibers in histological sections, Molecular biology: RNA Isolation RT- PCR etc. Animal Experiment Immortalization, cell counting etc. Immunohistochemical method: Frozen – section, Subcutaneous Tumor injection Determination of Tumor growth in nude mice.

Internship in the Biology Lab, Animal Experiment: Subcutaneous Tumor Injection to nude Mice.