Roxana Galvan Email and Phone Number

Yale Cancer Center - Clinical Trials Office

Site Start Up (SSU)- North America

Site Start Up (SSU)- North America-Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules, with moderate oversight from the SSU Country Manager. -Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified. -Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance. -Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.). -Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.-Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SSUL. May serve as a point of contact for the PM/SSUL (or designee) during start-up on allocated projects. Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.

Pediatrics- Hematology Oncology Clinical ResearchPrepares and submits protocol and regulatory related documents in order to obtain IRB (local and/or commercial) and other regulatory agency approval for the conduct of clinical researchCommunicates and maintains a positive relationship with internal coordinators, IRB members, sponsors, CROs, regulatory agencies, and other participating sites Coordinates and manages up to 150 internal protocols ranging from retrospective chart reviews to Phase IV studiesCoordinates and manages up to 20 participating sites in multi‐center studiesAssists, prepares and maintains regulatory binder(s) for internal and external regulatory auditsCoordinates planning, preparation, data collection, assembly, review and publication ofregulatory submissions to the FDA and other government agenciesReports and responds to regulatory agency inquiries or commentsSupports PIs and study staff by assisting in the data collection, notification, and reporting required for adverse eventsMaintain knowledge of regulatory guidelines and updates on laws through articles and training courses

Pediatrics- Hematology Oncology Clinical ResearchPrepares and submits protocol and regulatory related documents in order to obtain Institutional Review Board (local and/or commercial) and regulatory agency approval for the conduct of clinical researchCommunicates and maintains a positive relationship with internal coordinators, sponsors, regulatory agencies, and other participating sitesAssists, prepares and maintains regulatory binder(s) for internal and external regulatory auditsCoordinates planning, preparation, assembly, and review of regulatory submissions to the FDA and other government agenciesReports and responds to study team, sponsor, and regulatory agencies inquiries or commentsSupports Principal Investigators and study staff by assisting in the notification and reporting required for Adverse EventsMaintain knowledge of regulatory guidelines and updates on laws through articles and training courses

University of Texas MD Anderson Early Phase Clinical Research ConsortiumNCI Division of Cancer Prevention’s Phase 0/I/II Cancer Prevention Clinical Trials ProgramCollect, maintain, and submit all regulatory documents for the N01 Consortium Lead Organization (CLO) and Participating Organizations (PO)Maintain master regulatory list for all N01 Consortium protocolsSubmit new and amended departmental and N01 Consortium protocols to MD Anderson’s IRBCollect, maintain, and store CIRB, DCP, and PO notification documentsProvide weekly updates regarding N01 Consortium protocolsMaintain Clinical Cancer Prevention and N01 Consortium Protocol Prioritization listPerform other administrative duties, as assigned (scheduling audits, annual NCI meetings, teleconferences)

Cancer Prevention Center- Healthy Living Clinic InternCollect and assess retrospective patient data to determine clinic outcomes Organize Patient Education documents and handouts for the Healthy Living clinic, while ensuring that they are current and stockedObserve providers during patient interactionsDirect patients into their consult room to collect personal health data Mail various documents and handout to patientsMedical charting

Oversee daily activities of the store and cashiersDelegate tasks to cashiers and other employeesProvide customer services to all customers

Provide customer services to all customersOversee cleanliness and maintenance of the store