• Responsibilities include global study start-up management, serving as the project manager of study start-up; owns and coordinates all site identification & recruitment activities and site activations in all applicable countries• Acts as the final internal point of escalation and as the sponsor’s primary point of contact for study start-up; achieves consistent positive client feedback• Oversees and is accountable for the regional Site Activation Lead(s) activities’, ensuring site activations in each country are on track, updates are properly reflected in the Clinical Trial Management System, and regional risks and mitigations are documented and thoroughly discussed• Ensures the SSU team is properly trained using data and metrics to monitor performance and provide feedback• Identifies, reviews and analyzes global SSU risks that impact timelines and milestones and effectivelycollaborates with the sponsor, functional team leads and internal regional teams to discuss strategy and riskmitigation planning• Presents timely status reports on feasibility and global SSU activities during internal & client meetings• Actively leads internal regional team meetings, providing support to help ensure regulatory submissions and siteactivations occur within the projected timelines; recently helped achieve completing a regulatory submissionwithin our projected timeline for 7 EU countries• Ensures all assigned studies meet contractual and budgetary commitments• Creates, maintains, and facilitates sponsor approval of SSU documents, including the Project Start-Up Plan• As a study start-up SME, actively mentors other SALs at ICON on global SSU responsibilities, BDM preparation & ICON’s SSU reporting tool • Presented in 3 Bid Defenses in 2023, which also resulted in ICON as the CRO awarded the study

• Promoted from Start-Up Lead 1 (Sep 2021 - Mar 2022) to Start-Up Lead 2 (Apr 2022 - Sep 2023); due to ICON acquisition, both positions were titled Site Activation Lead • Managed and led all aspects of study start-up activities at the regional level from the start of the study until the last contracted site was activated in each assigned country• Used available tools to establish site activation forecasts and note critical path activities for assigned countries• Oversaw and was accountable for the SMA’s and SAS’ activities and deliverables, ensuring timely collection and submission of essential documents for assigned sites, accurate updates in ICON’s CTMS system, and adherenceto time entry guidelines• Oversaw site identification and recruitment activities for allocated countries and completed Central IRBsubmissions in North America• Identified, documented, and analyzed risks to regional start-up timelines for assigned countries and worked withregional study teams to mitigate those risks• Drafted country essential documents and IP Release Forms; performed an independent QC of IP packages forsites within assigned countries• Met with Senior SAL weekly to report SSU updates for assigned countries• Conducted internal meetings with regional SSU teams, providing guidance and leadership to the teams• Facilitated the transition of study activities in assigned countries to the maintenance team once all sites inassigned countries were activated• Served as a temporary Senior SAL on a global study involving North America, Spain, France & South Korea• Was a supporting Senior SAL on a global study in NA, LATAM, APAC and the EU from• Managed a 4-country global study in NA and the EU from Nov-22 to Jul-24, achieving both FSA and LSA for the study• Managed a 14-country global study NA, LATAM, EU and APAC from May-23 to Jul-24, achieving FSA in Jul-24• Presented on 1 Bid Defense in 2022, which resulted in ICON being awarded the study

• Responsibilities we’re the same as Site Activation Specialist • Assumed additional responsibilities of conducting Trial Master File and Essential Document trainings for new hires and mentoring other SAS’ and shadowing Start-Up Leads in preparation for int

• Was responsible for managing investigative sites during the SSU and site activation process in the United States and Canada; primary site contact/liaison for site management issues• Assisted in identifying potential sites for project participation by performing feasibility tasks, utilizing site recruitment questionnaires to obtain project required information• Communicated with investigative sites and internal team members to predict timelines for site activation and ensure all activation requirements are met• Collected and reviewed site essential documents and submitted complete IP packs for both internal and sponsor review and approval prior to site activation• Negotiated and finalized ICFs with sites and supported site staff with local and central IRB submissions• Set up and maintained site-related data and documentation in ICON’s CTMS, as required• Analyzed data and metrics relating to the site activation process, noting any risks at the site level• Facilitated the transition of site level activities to the maintenance team once sites were activated• Active mentor of the SSU mentor group; helped provide guidance to newly hired SAS’• Activated 10 sites in November 2020 for a COVID-19 trial, which led to sponsor satisfaction and the ability formore patients to enroll in this trial faster, as we were continuing to find a vaccine globally

• Was responsible for managing assigned sites in NA through the maintenance and close-out phase• Actively communicated with sites regarding subject recruitment, screening & enrollment; acted as liaison withinternal and external teams, was responsible for informed consent form updates, close-out activities, and IRBamendment submissions.• Ensured client and investigator obligations were being met and in compliance with applicable regulatoryrequirements, ICH/GCP guidelines, and PRA SOPs• Kept ICON CTMS accurate and current for assigned sites to ensure audit readine

• Collected, completed, maintained, and filed all essential regulatory documents required by sponsors or Contract Research Organizations• Was responsible for the initial and ongoing IRB submission process, regulatory documentation for all Oncology Clinical Trials, informed consent negotiation and finalization, communication with Sponsors and CRO’s, coordination of sponsor/CRO site visits & new staff onboarding and training.• Was an active member of the Clinical Trials Standard Operating Procedure (SOP) Committe

• Tracked key website and social media analytics• Compared social media statistics with other universities

• Actively assisted professors and students in research projects in the animal lab• Learned how to run behavioral experiments on rats, and record and analyze data

• Wrote about events occurring at SU that were displayed on the school’s website for prospective students• Contributed to website updates and advancements

• Provided tours for prospective students and shared information about Susquehanna University• Contributed to the achievement of obtaining SU’s largest ever incoming class

• Worked with the Regulatory team in the Clinical Trials Office; helped partake in regulatory filing, learned the IRB review process• Created training manuals for a Regulatory Coordinator and SSU Coordinator positions