Ashley Widmer Email & Phone Number

Mainz, Rhineland-Palatinate, De

Tarrytown, New York, Us

Tarrytown, New York, Us

Works closely with the Clinical Study Leader, and greater study team, to help manage Phase I/II oncology clinical research trials. Recurring tasks include, but are not limited to, CRO oversight and TMF maintenance. In addition to her work on the study team, Ashley also mentors 3 newer Clinical Study Specialists to help them succeed in the CSS role.

In addition to retaining all CTC duties, additional responsibilities include:• Assisting the CTM in preparation and QC of the monthly trial summary reports• Assisting the CTM with tracking study progress• Entering and maintaining study status updates (such as IRB approvals and enrollment information) into the CTMS• Distributing aging safety queries to the CRO for follow-up with site CRAs• Maintaining enrollment status update spreadsheets on a weekly basis for three separate studies• Addressing patient clinical trial inquiries received from ClinicalTrials.gov• Attending lab meetings as the Kyowa Clinical Operations representative• Assisting in ClinicalTrial.gov results entry• Chosen as a member of the first eTMF SharePoint implementation team and appointed a "Super User"• “Super User” for Kyowa’s budget management system, GrantPlan• Assists CTMs with creation of study site budgets in GrantPlan• Participating in sponsor site quality monitoring visits to assess CRO CRA’s and site’s performance

• Tracked study progress and maintained study status updates (site budget and contact status, vendor master service agreement and work order statues)• Entered contracts, change orders and work order into Kyowa’s electronic contract system• Tracked and managed site 1572’s, CVs and Financial Disclosure Forms• Maintained Clinical Operations study specific SharePoint sites• Created and maintained ClinicalTrials.gov registry for several studies• Reviewed and approved LabConnect vendor invoice payments• Responsible for maintenance and QC of the Trial Master File Sponsor Section• Completed oversight and review of CRO’s electronic Trial Master Files• Tracked sponsor team members’ study specific trainings and start/stop dates on study

Princeton, New Jersey, Us

o Assists the Clinical Project Manager with study management of multiple oncology studies ( phase I-III) -Drafted documents for sponsor review ( Communication Plans, Site Manuals, Process Documents )-Reviewed Protocol Amendments to see if any updates affect BioClinica documents/processes- Reviewed contracts and determined if Contract Amendments were required. If so, prepares the necessary Change Order request for review.-Utilized the internal tracking databases to determine correct client monthly billing-Helped manage studies in their different life cycle stages: start-up through close out procedures-Lead sponsor teleconferences in the absence of the Clinical Project Manager-Conversed directly with sponsors via phone and email to discuss study questions/updates-Reviewed study metrics to actively report any study needs-Prepared Bioclinica reports to be sent to sponsors-Monitored the internal databases to ensure all media processing and review was completed correctly-Performed Source Document QC-Supervised two Project Support Specialists-Createed study kick-off presentation slides

Princeton, New Jersey, Us

o Assisted the Assistant Project Manager with sponsor questions and answers e-mails from staff, sponsors and CRO’s regarding BioClinica’s requirements, including questions regarding charters, communication plans and missing media/exam components. o Assisted sites in the resolutions of quality issues with the patient media received and prepares reads for radiologist evaluation. o Performed individual teleconferences with sites to inform clients of BioClinica’s policies and practices and of specific guidelines for clinical trial protocol.o Assisted with several sponsor calls weekly, answering questions regarding on-site progress, producing meeting minutes and researching project status and issues for placement in meeting agendas.o Served as senior informational source for staff and utilize expert knowledge of the BioClinica database to solve problems for project manager. o Oversaw media processing aspects and reported consistent media processing issues to project manager for resolution.o Served as Project Leader for Clinical Operations for 6 months, delegated and supervised project coordinator’s daily tasks, quality checked study progress sent to sponsor and regularly corresponded with, answered questions and pulled study progress metrics for sponsors. o Assisted the Assistant Project Manager and Project Manager with various tasks, including radiology source document QC and IWRS notifications to sites.

New Brunswick, Nj, Us

o Participated in laboratory-based experiments. o Cataloged insects and performed fieldwork with little to no supervision.