Sr. Clinical Research Associate

• Sep 2023 - Present

Owner / Lead Chef

• Apr 2020 - Aug 2023

•Created company to provide customers lacking the resources with first-class satisfying and nutritious meals. • Developed basic and customizable meal plans catering to dietary restrictions, including macronutrient counting, weight loss, muscle gain, and disease management. •Directed company expansion: - Increased profit growth over 500% from low 5-figure to 6-figure income within 1.5 years while maintaining low overhead. - Developed consistent workflow and SOPs to optimize resource use and consistently produce high quality meals. - Hired and led team for on-site catering events and increased production. •Wrote Something to Munch cookbook detailing cuisine and culinary background. Show less

Lead Baker

• Apr 2019 - Apr 2020

• Responsible for daily oversight and production of all baked goods, along with development of new product offerings. • Created a dynamic food cost calculator to manage variable food costs and improve profit margins. • Led team of bakers to improve quality and consistency of baked goods, increase sales, and expand customer base. • Assisted in growing the brand name and increasing product exposure via social media and marketing • Responsible for daily oversight and production of all baked goods, along with development of new product offerings. • Created a dynamic food cost calculator to manage variable food costs and improve profit margins. • Led team of bakers to improve quality and consistency of baked goods, increase sales, and expand customer base. • Assisted in growing the brand name and increasing product exposure via social media and marketing

Project Manager, Early Development Services

• Sep 2016 - Apr 2019

•Primary cross-functional communications and meetings lead for external stakeholders including clients (biopharmaceutical company or CRO), partnering labs, data management companies and other vendors. •Initiated kickoff meetings (recorded and distributed minutes), management timelines in regular meetings between stakeholders, and acted as on call point-person for any queries. •Tailored SOPs to be study specific. •Collaborated with clinical study managers to define early development and/or sample tracking needs and to develop appropriate training materials for investigative sites and staff. • Coordinated with departmental director and other project management staff to develop study setup activities, SOP’s, SOW’s, laboratory manuals, and requisition forms. •Led team of Assistant Project Managers and Project Coordinators, inspiring team to achieve goals, providing feedback and mentorship, and building trust and respect throughout the team. • Tracked KPIs for management team, implementing agreed measures to improve team performance. • Oversaw data management and sample management for multiple global phase I-III clinical studies. • Supervised document management from study setup to completion and ensuring compliance for client audits. Show less

Clinical Research Associate and Laboratory Manager

• Sep 2014 - Jun 2016

• Led bioinformatics team researching clinical biomarkers with RNA samples and preformed biochemical assays for discovery projects. • Coordinated experiments and logistics with CROs, academic and medical collaborators, and major vendors. • Managed chemical inventory, sample databases for discovery, preclinical, clinical, and CMC activities as well as clinical samples for >12 phase 1-3 clinical trials and >40 independently sponsored trials. • Assisted in writing and editing clinical protocols, TMF files, and GCP/ICH study document compliance. • Ensured lab members were compliant with health and safety regulations. • Ensured function and calibration of all lab equipment. • Oversaw comparative research for potential new laboratory equipment and vendor testing. •Prepared, organized, and tracked shipments of medical supplies to over 300 medical facilities worldwide. •Trained clinical trial staff on proper collection, processing, and shipping procedures. Show less