Alexandra Lacroce Email and Phone Number

Study lead since Oct 2022• Liaises and maintains relationships with Contract Research Organizations (CROs), vendors, and clinical sites to ensure seamless and efficient trial execution and adherence to timelines• Supports cross-functional teams spanning Data Management, Regulatory Affairs, Clinical Science, Legal, Translational, and Pharmacovigilance, and holds weekly meetings to foster effective communication and collaboration• Continues all responsibilities listed in previous role (Senior Clinical Trial Management Associate)

• Contributes to study-related documents such as protocols, Informed Consent Forms (ICFs), study manuals (Pharmacy, Cell Therapy Lab, Lab), patient forms, Case Report Forms (CRFs), and slide decks (Introductory Calls, Site Qualification and Initiation Visits, re-trainings)• Successfully coordinates site start-up (feasibility, selection, activation), patient recruitment, data review, monitoring activities, kit supply, and Investigational Medicinal Product (IMP) shipments simultaneously across CAR T-cell therapy Phase I/II clinical trials• Creates and maintains efficiency-enhancing templates (letters, reports, budgets) and trackers (site start-up, essential document collection and regulatory submissions, patients and data entry, site visits, global IMP shipments, risk and issue management)

• Efficiently and accurately managed data spanning multiple clinical trials, with a proficiency in Electronic Medical Record (EMR) and Electronic Data Capture (EDC) systems - Coordinated successful completion of a 4-year backlog for the most robust Phase III protocol in the Breast Service - Improved data compliance by 10% and maintained above 94% compliance throughout the COVID-19 pandemic • Managed elaborate clinical trials and implemented novel ways to amplify organization and streamline communication across teams - Crafted new workflows to increase form completion and significantly reduce missed protocol timepoints - Reestablished contact with patients across three separate trials that had not been actively followed• Proactive in seeking additional projects and providing support across numerous protocols• Certified in Good Clinical Practice (GCP) and Human Subjects Protection (HSP)

• Worked collectively with all departments and promoted teamwork, interdepartmental functioning, and harmony• Understood pharmaceutical clients' needs for brands; provided strategic guidance, e.g. the creation of new slide decks for product theaters and innovative ways to conduct speaker trainings; and created opportunities for increased business• Collaborated with pharmaceutical clients and the HWP team to ensure successful execution of programs and development of quality resources for programs, e.g. presentation slide decks and appropriate feedback forms, which were aligned with the brand strategy• Pioneered implementing consistency of executive summaries provided to clients and across brands

• Coordinated activities and schedules for the CEO as required, ensuring external client satisfaction and internal employee and management interaction goals• Served as liaison internally to all departments assuring prompt, effective, and efficient meeting scheduling and completion of actionable items• Transcended duties by participating in various team meetings

• Enforced corporate policies and supervised a team of ~20 employees while providing a safe and friendly environment for members• Facilitated team meetings and monthly trainings• Responded promptly to member inquiries and delivered premier customer service through building relationships with the clientele

Researched nutritional topics and authored a series of articles for a dietitian’s expanding practice

• Executed Occupational Therapists’ treatment plans, taught patients mobility and movement techniques, and monitored and provided instruction to patients• Conducted clerical responsibilities and brought attention to oversights that could be improved

• Tested and analyzed milks, using MilkoScan and cryoscope instruments, and cheeses, using FoodScan, for their chemical and physical properties, and created agars to test for any unwanted bacteria or pathogens• Examined and experienced the legalities and preventive approach of a Hazard Analysis and Critical Control Points (HACCP) plan

• Tested and analyzed wines and their contents, utilizing instruments such as the DL53 Titrator and Densi Alcomat, to ensure adherence to legal guidelines• Operated efficiently with an international team in a fast-paced environment• Set up and assisted with wine tastings, cooking classes, and tours around the winery• Participated in business meetings with distributors and large direct customers

Advised students of all levels how to write structurally and materially sound papers

• Observed a doctor of internal medicine during patient appointments and experienced a clinical environment• Identified how to communicate effectively with patients

• Tested and analyzed wines and their contents to ensure adherence to legal guidelines• Operated efficiently with an international team in a fast-paced environment• Set up and assisted with wine tastings, cooking classes, and tours around the winery• Participated in business meetings with distributors and large direct customers