Malachy Ekeh Email & Phone Number

United States

• Prepares, conducts and reports on activities related to the completion of site selection, initiation, routine monitoring and close-out visits.• Monitors patient enrollment to ensure recruitment targets and project timelines are met at the site and/or country level.• Performs source data verification and follows up on data queries at the site level, on-going review of any Risk Based Monitoring related information influencing data quality and frequency of site visits.• Ensures accurate and timely reporting and follow up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations.• Acts as the main line of communication between the Sponsor and the site.

United States

• Coordinated and conducted activities involved in initiating, monitoring, and completing clinical research studies.• Ensured studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements.• Collected all clinical study essential documents.• Ensured that CRO activities and timelines are in coordination with project requirements.• Implemented and document communication with CRO and laboratories to ensure project progress.

United States

• Provided site management and monitoring support for sponsored clinical studies.• Performed on-site pre-study/qualification, initiation, routine, and close-out visits. Prepare site visit reports and provide assistance to site staff in resolving deficiencies.• Educated and trains site and study staff in management of sponsored studies, including assurance to regulatory and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) compliance.• Collected and processed regulatory documentation for investigational studies in compliance with required guidelines.• Assisted in protocol, Informed Consent, and CRF design and review.• Developed and demonstrate understanding of and apply therapeutic area knowledge to assignments and project-related issues.

Houston, Texas, United States

• Ensured efficient monitoring of all trials by ensuring that the data is clean and entered accurately into the sponsor EDC in timely fashion.• Supervised site initiation activities as well as oversee the set-up and maintenance of studies.• Created and submitted Regulatory and associating documents as needed to start new clinical trials.• Maintained both new and ongoing IRB processes.• Revised IRB submissions in response to identified problems and resolved issues in a timely manner.• Created and maintained up to date Source Documents (paper and electronic) for each study.