Carolina Amador Carrascal,Phd Email & Phone Number

Burlington, Massachusetts, Us

Leading cross-functional teams to ensure studies are adequately designed to meet all endpoints and completed in compliance with regulations and standard operating procedures. Contribute to recruiting clinicians, KOLs, clinical research sites and other partners to participate in both new and ongoing research with diagnostic ultrasound point of care device (class IIa hardware and software) including Artificial Intelligence software. Work with Butterfly Network Legal, Finance, and Clinical product teams to develop research contracts and budgets. Manage and oversee clinical research team. Accountable for all full-cycle clinical research projects from feasibility, pivotal for regulatory clearance, and post-market investigator-initiated trials. Functional manager accountable for maintaining all clinical research and clinical investigation Standard Operating Procedures.

Amsterdam, Noord-Holland, Nl

Collaborated with cross-functional teams to deploy processes for clinical development of comprehensive strategies and plans to generate clinical evidence. Assembled and oversee highly specialized three-member clinical development team, answerable for generating Clinical Evaluation Plans and Reports, Post-Market Clinical Follow-up Plans and studies, adhering to all regulatory standards (EUMDR, MEDDEV and ISO) for over 60 (Class III, IIb and I) medical devices. Conducted precise reviews of diagnostic and therapeutic medical devices literature to establish medical, technical, and clinical state-of-the-art confirmations of clinical benefit claims. Contribute key medical and scientific input and guidance to cross-functional product development teams. Analyze, define, and support the execution of process improvement initiatives to resolve issues relating to clinical evaluations, PMCFs and clinical evidence strategies. Produce and communicate clinical strategies and clinical evidence tasks to internal stakeholders.

Amsterdam, Noord-Holland, Nl

Composed detailed project plans, established goals, set milestones, and specified gate requirements and dates, transfers, generated clinical trial parameters and contracts. Cultivated critical relationships with clinical collaborators and influential stakeholders. Guided a high-profile project with a specialized cross-functional team consisting of engineers, developers, medical advisors, clinical scientists, and medical advisors. Partnered with research program management and ultrasound corporate leaders to define ultrasound project roadmaps and innovation opportunities. Orchestrated the conceptualization of influential product improvements, contributing to industry leading intellectual property advances, and technology transfers, leading to exponential growth of the business.

Singapore, Singapore, Sg

Planned and constructed comprehensive weekly webinars and highlight reports, documenting the previous week's assignment submissions. Administered moderation and weekly student feedback on weekly discussion topics.

Rochester, Minnesota, Us

Directed clinical 100+ subject human study to evaluate kidney transplant rejection utilizing shear wave elastography. Organized pilot study of acoustic radiation force induced creep-recovery method validation with finite element simulation, tissue mimicking phantoms and in vivo human healthy livers. Joined forces with Pontificia Universidad Catolica de Peru on a collaborative study to compare shear wave elastography and backscatter attenuation coefficient of in vivo healthy livers.

Rochester, Minnesota, Us

Undertook the study of the effects of phase aberration and ultrasound attenuation in shear wave elastography with acoustic field simulation software, finite element simulation and experimentally. Coordinated and carried out human clinical studies to evaluate the abdominal application of shear wave elastography in healthy subjects. Formalized the framework and parameters to the clinical study to determine kidney transplant rejections with shear wave elastography.

Rochester, Minnesota, Us

Rochester, Minnesota, Us

Configured a research ultrasound scanner to prototype and optimized the application of the acoustic radiation force induced creep recovery method. Developed and configured shear wave elastography in a research scanner to be used in human studies. Assessed and confirmed the ultrasound viscoelasticity method with tissue mimicking phantoms.

Rochester, Minnesota, Us

Verified and implemented shearwave dispersion ultrasound vibrometry method to swine renal cortex ex vivo and in vivo. Adapted research scanners to configure ultrasound-based shear wave elastography methods in research. Produced acoustic radiation force induced creep and creep-recovery method (ARFIC and ARFICR) for viscoelastic properties characterization. Supported professors and students with assignments and instructional material on two-dimensional digital signal and image processing.

Rochester, Minnesota, Us

Rochester, Minnesota, Us

Rochester, Minnesota, Us

Phd, Biomedical Sciences

Executive Program, Developing And Managing A Successful Technology Strategy

Be, Biomedical Engineering

Education record