Didi Edo Email & Phone Number

Brantford, On, Ca

 Ensure that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements. Coordinate with various departments and assist to prepare all regulations for clinical trial activities and ensure adherence to all timeframe and maintain accuracy in process. Administer all clinical aspect of study and recommend changes in implementation of various plans and design all project metrics and timeframe for project completion. Collaborate with various teams for various research activities and assist in vendor management and resolve all issues through negotiation. Provide assistance in developing training methods and implement new project initiatives. Assist in developing project metrics and reporting processes. Develop project specifications and ensure that each project is conducive to the supplied specifications. Research and collect data necessary for each project and evaluate the outcome of project information. Monitor team performance against contract and client expectations and according to key performance metrics Manage vendor including sourcing, vendor plan reviews, and payment approval based on SOW. Ensure compliance with study tools, training materials and standard processes, policies, and procedures. Review monitoring visit reports. Identify project risks and issues and take appropriate measures to ensure that they are addressed. Execute and guides project operations through the use of systems development and project management methodologies accepted by the industry. Perform site visit report review for assigned projects and tracks site visit report metrics to ensure compliance. Develop the annotated site visit reports and monitoring tools such as source data verification worksheets. Develop the PSV and SIV training slides

Canada

 Prepared trial-related documentation including protocols, case report forms, and consent documents. Oversaw site and staff performance including monitoring all types of clinical trials; participate in all types of site visits (PSSV), (SIV), (IMV) and (COV). Determined the logistics of each drug trial and handle investigator selection and patient selection duties. Ensured the site Investigator Folder is up to date and mirrors sponsor’s TMF. Monitored site drug accountability against IWRS by reviewing supply, storage and performs interim and the final return of investigation products.  Responsible for collecting regulatory documents from site and filing in eTMF. Organized startup meetings and study site initiation conferences. Coordinated the movement of laboratory samples and ensure that procedures are set for optimization of patients into the trial. Ensured that the process of obtaining informed consent is adequately performed and documented for each subject/patient, as required per protocol/SOP.  Reviewed clinical trial reports written by junior team members. Planned requirements for clinical trial materials, set up and monitor systems and maintain procedures to account for trial materials. Participated in teleconferences and meetings with Sponsor or/and study staff. Participated in Sponsor Audits. Developed Pre site and SIV training materials

Canada

 Developed and implemented a set of protocols for clinical research work which are being used as the basis for each trial program. Interacted with field monitors to ensure appropriate management of study issues. Coordinated activities at investigational sites. Performed submissions and notifications to Regulatory Authorities, IECs and other bodies according to applicable guidelines, regulatory requirements, and SOPs. Identified potential unreported Adverse Events and Serious Adverse Events while reviewing patient’s charts and appropriately processes according to study protocol guidelines and sponsor SOPs. Developed study tools and guides for each clinical trial. Assisted in the development of study timelines and priorities. Served as the primary clinical liaison between drug development teams and other departments. Coordinated and conducts PSSV, SIV, and COV visits in order to assess the qualification of potential study sites, to initiate and instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected, and to terminate studies. Trained and re-trained of new research personnel, including Study Coordinator, Investigators, and site pharmacists. Assisted in evaluating and investigative sites and conducting co-monitoring visits. Participated in monitoring study safety and handling data review and discrepancy resolution. Performed study initiation activities and reviewed protocols and regulatory issues. Documented accountability, stability, and storage conditions of clinical trial materials according to sponsor’s instructions

Canada

 Managed operations workflow by developing schedules, gathering resources, implementing productivity standards, maintaining reference manuals, and implementing new procedures. Entered data into the EDC and resolved queries for assigned studies. Coordinated the execution of human subject’s research protocols including subject recruitment and data collection. Coordinated meetings with internal and external stakeholders. Conducted basic statistical analyses, such as descriptive statistics. Assisted in writing and editing study materials, reports. Participated in ongoing trainings related to the proper conduct of research

Canada

 Followed all laboratory safety rules and regulations. Performed basic laboratory procedures including weighing samples. Performed maintenance, calibration and troubleshooting of weighing scales with supervision and guidance from senior staff. Provided general lab support