Andrew Phan Email & Phone Number

Miami, Florida, Us

Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables.Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sitesPartners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data.Create and develop study trackersResponsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc. Responsible for reviewing assigned study related plans, processes, agreements, and guidelinesFollowing and implementing assigned study related plans, processes, agreements, and guidelinesReviews and approves essential document packages to enable timely site activations.Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is completeProvides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed. Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMFEnsures the study is “inspection ready” contemporaneously

Morrisville, Nc, Us

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes• Reconciles contents of the ISF with the Trial Master File (TMF)• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan

Dublin, Ie

-Work with study teams and individual TMF owners to establish study-specific TMF structure and to ensure quality of TMF and TMF content, according to the established processes -Create, maintain and facilitate sponsor approval of the TMF plan and filing structure and interact with sponsors / vendors as needed to ensure required TMF deliverables are provided in accordance with study timelines.-Oversee the quality review process of the study ensuring adherence to TMF Plan, quality standards and study timelines.-Provide regular status reporting on TMF quality, completeness and audit readiness while identifying and mitigating potential risks and communicating as needed to study team.-Monitor the quality, completeness, and overall inspection readiness rates of the TMFs for all functional areas managing TMF content.

Duarte, Ca, Us

Precision Medicine: Oncology (Solid Tumor) Department-Manages the precision medicine protocol consenting documents-Responsible for consenting and auditing consents-Delivery and development of biospecimen kits-Manages patient information in OnCore (CTMS) and Epic (EMR)

Los Angeles, Ca, Us

Andrew Nel Lab: Study development of new nanoparticle drug delivery systems for the treatment of pancreatic cancer. Manage inventory/stocking, autoclave reagentsMake buffers and media; transport and dispose of medical and chemical waste