Amy Huselton

- Responsible for the management of clinical study documents from study start through final archival, ensuring compliance with company Standard Operating Procedures (SOPs) and processes - Ensure data mastering for all sites participating in UBC studies (address, NPI, signature status etc.) - Serve as central storefront for all physician data associated with UBC clinical, periapproval and REMS programs - Ensure clinical sites are ready for participation as soon as a UBC study begins - Work directly with UBC Clinical Operations team, ensuring data-readiness of the operational management of the UBC CTMS System (UBC Track®)

- Perform Pre-Study, Initiation, Interim Monitoring and Close Out visits - Responsible for the collection, review, and integrity of all data collected on the case report forms at the clinical site - This is inclusive of, but not limited to inclusion/exclusion criteria, adverse drug/event reconciliation, central laboratory values and evaluation, regulatory binder, drug accountability and physician administered tools

- Addressed and resolved all internal and external clinical issues for client research projects managed by PRA - Managed investigational sites to ensure compliance with the trial protocol, ICH-GCP and applicable regulations - Ensured that clinical staff assigned to specific clinical research projects complete tasks in accordance with the project contract, PRA policies, ICH-GCP and applicable regulations, and applicable SOPs - Oversaw 2 phase IV studies; responsible for training and trip report review for 8 CRAs - Authored Clinical Management Plans and Case Report Form completion guidelines for newly awarded programs - Participated in client Bid defense and Kick off meetings

- Promoted annually from CRA II, to CRA III, to Senior CRA based on study delivery & performance - Responsible for monitoring & managing multiple sites participating in 4 protocols in parallel - Routinely involved with investigator recruitment & identification driving study delivery and patient accrual - Robust involvement with all areas of study monitoring including Pre-Study, Initiation, Interim & Close-out visits in strict audited compliance with ICH, FDA, PPD specific and Sponsor specific Standard Procedures - Long history of source document verification in complex indications and in a wide variety of clinical settings and practices for completeness, clarity, legibility with strict adherence to protocol requirements CRF discrepancies and/or clarifications via site visit, telephone, fax and E-Mail - Performed drug accountability and ensured prompt reporting of adverse events, familiar with studies that require blinded drug accountability - Collected and reviewed essential regulatory documents, assisted with the development of Source Documents and Attended investigator meetings to support training and kick-off of studies - Assisted in 2 database locks and line listings

- In-house role responsible for site activation, regulatory document collection, study amendment process, and other related tasks of study delivery, study compliance and interim study document review and updating for necessary deliverables - Performed Initiation and Interim Monitoring visits. Responsible for the collection, review, and integrity of all data collected on the case report forms at the clinical site. This was inclusive of, but not limited to inclusion/exclusion criteria, adverse drug/event reconciliation, central laboratory values and evaluation, regulatory binder, rating scales, drug accountability and physician administered tools. - Involved as primary monitor for 3 of the 5 sites that were high-enrollers and protocol champions - Performed in-house clinical review of CRFs, generated and resolved queries - Involved in the coordination of drug shipment and accountability as well as other study supplies/materials - Responsible for review and submission of regulatory documents to central and local IRBs