Experienced scientist specializing in oncology and hematology clinical trials. My related skills include:Hard skills:- Creating study documents in accordance with study and SOP requirements-Monitoring adjudication results and re-training reviewers as necessary - Developing and executing data quality monitoring plans, including ongoing data quality monitoring and query management- Mitigating quality incidents by directly working with sponsors to understand the issue and finding and executing successful solutions- Expertise in image processing and quality control across multiple modalities, recognized as one of two experts in my previous company for processing and analyzing PET scans using internal software- Responsible for creation of image acquisition guidelines- Specialization in RECIST 1.1, IMWG, iwCLL, and Lugano criteria- Primary support for oncology and hematology studies- Interpreting study protocols and following SOPs. Recognising protocol deviations and updating documents based on protocol amendments- Training sites and internal employees on various software and modalities- Creating reviewer training materials, and conducting reviewer training sessions- Collaborating closely with clients to meet specific requests and address concerns-Analyzing adjudication rates and re-training reviewers as necessary - Performing UAT, editing and reviewing eCRFs, and conducting various forms of quality monitoring- Proficiency in Microsoft applications and EDMS- A comprehensive understanding of managing clinical trials from start-up to closure, encompassing scientific, project management, image processing, and engineering perspectives- Recruited in high stake situations with clients using problem solving skills to find and execute effective solutions that contribute to client trust in our quality -Recruited to develop risk mitigation strategies Characteristics:-Team player always happy to help and cares about others success as much as my own-Keen attention to detail to ensure first time quality -Excellent time management skills having supported over 20 studies and ensuring milestones were met ahead of time or on time- Considers my quality of work as a reflection of my character. Strives to build a reputation as someone who is reliable with skills and expertise critical to answer questions, support team members, and drive productivity-Stubborn determination to excel at any role Highly recommended by Chief Medical Officer, directors, and colleagues. Recommendations can be found in my profile.
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Medical And Scientific Affairs AdvisorClario Aug 2024 - PresentMclean, Virginia, United States -
Medical Research ScientistCalyx Jan 2022 - May 2024Ithaca, New York, United States*Calyx was formerly PAREXEL*Utilized time management and leadership skills to ensure that study milestones were met ahead of or on schedule for over 20 concurrent studies. Created study documents and performed ongoing data quality monitoring, consistently providing clean data by applying keen attention to detail and ensuring adherence to study requirements. Frequently sought out for my expertise and unique skill sets, I used problem-solving skills to find and execute solutions in… Show more *Calyx was formerly PAREXEL*Utilized time management and leadership skills to ensure that study milestones were met ahead of or on schedule for over 20 concurrent studies. Created study documents and performed ongoing data quality monitoring, consistently providing clean data by applying keen attention to detail and ensuring adherence to study requirements. Frequently sought out for my expertise and unique skill sets, I used problem-solving skills to find and execute solutions in high-stakes situations, fostering a sense of trust and satisfaction among clients. Show less -
Senior Imaging Research SpecialistCalyx Apr 2021 - Jan 2022Recognized as a top performer, I was responsible for training colleagues to enhance their understanding of image quality and image processing, including the use of third-party software. Specializing in PET and PET analysis software, I frequently ensured timely deliverables by correcting improperly processed PET scans, thereby preventing client concerns. I possess a deep understanding of various imaging modalities, their functions, processing techniques, and quality assurance, ensuring the… Show more Recognized as a top performer, I was responsible for training colleagues to enhance their understanding of image quality and image processing, including the use of third-party software. Specializing in PET and PET analysis software, I frequently ensured timely deliverables by correcting improperly processed PET scans, thereby preventing client concerns. I possess a deep understanding of various imaging modalities, their functions, processing techniques, and quality assurance, ensuring the accuracy of reviewer assessments. Show less -
Imaging Research AssociateParexel Sep 2016 - Apr 2021Billerica, MassachusettsRecognized as a top performer, I was responsible for training colleagues to enhance their understanding of image quality and image processing, including the use of third-party software. Specializing in PET and PET analysis software, I frequently ensured timely deliverables by correcting improperly processed PET scans, thereby preventing client concerns. I possess a deep understanding of various imaging modalities, their functions, processing techniques, and quality assurance, ensuring the… Show more Recognized as a top performer, I was responsible for training colleagues to enhance their understanding of image quality and image processing, including the use of third-party software. Specializing in PET and PET analysis software, I frequently ensured timely deliverables by correcting improperly processed PET scans, thereby preventing client concerns. I possess a deep understanding of various imaging modalities, their functions, processing techniques, and quality assurance, ensuring the accuracy of reviewer assessments. Additionally, I gained project management-related skills by assisting with data reconciliation and case management tasks. Show less -
Research AssistantUmass Medical School Jan 2013 - May 2014• Managed mouse colonies for Post-Docs • Assisted with NIH-funded core facility with in vivo insulin-mediated uptake studies (Hyperinsulinemic-Euglycemic Clamp) • Conducted molecular works including PCR, DNA/RNA isolation, and gel electrophoresis • Assisted with Glucose Uptake Assays of Mouse tissues from in vivo studies • Contributed to literature for experimental protocol • Guided new interns with information about the lab and experiments conducted • Buffer and reagent… Show more • Managed mouse colonies for Post-Docs • Assisted with NIH-funded core facility with in vivo insulin-mediated uptake studies (Hyperinsulinemic-Euglycemic Clamp) • Conducted molecular works including PCR, DNA/RNA isolation, and gel electrophoresis • Assisted with Glucose Uptake Assays of Mouse tissues from in vivo studies • Contributed to literature for experimental protocol • Guided new interns with information about the lab and experiments conducted • Buffer and reagent preparation • Documentation and data entry Show less -
Research AssistantWorcester State University Jan 2013 - May 2013Worcester, MassI was an assistant for a graduate student whose thesis involved utilizing transposon-mediated mutagensis to identify the function of biosynthesis genes. My duties included maintenance of bacterial culture, plasmid DNA isolation, gram staining, restriction digestions, gel electrophoresis, media prep, and data integrity.
Caitlyn Kearns-Galeano Education Details
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Biotechnology -
Biochemistry
Frequently Asked Questions about Caitlyn Kearns-Galeano
What company does Caitlyn Kearns-Galeano work for?
Caitlyn Kearns-Galeano works for Clario
What is Caitlyn Kearns-Galeano's role at the current company?
Caitlyn Kearns-Galeano's current role is Medical and Scientific Affairs Advisor.
What schools did Caitlyn Kearns-Galeano attend?
Caitlyn Kearns-Galeano attended Worcester State College, Harvard University.
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