Wendy Charles, Phd Email and Phone Number
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Wendy is a results-oriented Digital Health/Research leader with 20+ years of success identifying and prioritizing strategic research and healthcare needs aligned with business objectives. Spearheading new product introductions, quality assurance, resource management, and compliance infrastructure for healthcare and life sciences industry leaders, she is known for her unique ability to approach digital health opportunities from scientific, technology, compliance, and business development perspectives.Wendy is incredibly passionate about teaching and implementing emerging technologies, such as AI/ML and new digital health, to improve scientific research efficiencies and compliance. With a strong focus on continuous improvements, she is highly skilled at evaluating research deliverables/outcomes and promptly transferring results to end users in the digital and care pathway. She is also a motivational leader with experience building and guiding high-performing teams in delivering complex projects on time and above expectations. Wendy received a PhD in Clinical Science with a specialty in Health Information Technology from the University of Colorado Anschutz Medical Campus and M.S. in Psychology with an emphasis in Neuropsychology from The University of Memphis. She is certified as an Institutional Review Board Professional and a Clinical Research Professional._________________Core Competencies: Digital Health | Leadership and Teamwork | Strategic Planning/Execution | Research Design and Operations | Compliance and Quality Assurance | Program and Project Management | Data Analysis | Biotechnology/Artificial Intelligence | Business Development | Needs Assessments | Budget/Resource Management | Partnership Building | Program Management | Business Process Improvement | Management Consulting | Process Improvement
College Of Professional Studies At University Of Denver
View- Website:
- professionalstudies.du.edu
- Employees:
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Teaching Assistant ProfessorCollege Of Professional Studies At University Of DenverDenver, Co, Us
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Academic Director, Teaching Assistant ProfessorCollege Of Professional Studies At University Of DenverDenver, Co, Us -
Adjunct ProfessorUniversity College At University Of Denver Jan 2023 - PresentDenver, Co, Us❋ Teach in two programs. Within Health Informatics, I teach Foundations of Digital Health, Digital and Virtual Health, and Healthcare Data & Delivery. Within Information & Communications Technology, I teach Blockchain, Crypto, & Web3 regarding the design and functionality of distributed ledger technologies in financial services and general software architecture. ❋ Designed two courses with Instructional Design teams to implement best practices for syllabi, instructional material, assignments, quizzes, and grading rubrics.
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Adjunct ProfessorCu Denver Health Administration Programs Dec 2021 - PresentDenver, Colorado, Us❋ Teach Introduction to Health Information Technology. This graduate-level course addresses clinical science, health informatics, and digital health principles, including diagnostic technologies and electronic health records. -
Co-Editor In Chief, Decentralized ScienceFrontiers Jan 2024 - PresentLausanne, Vaud, ChCollaborate with Frontiers editorial support staff to define the scope of their section and recruit editors to their boards. Peer review and support and guidance to the editorial board. -
Associate Editor, Frontiers In BlockchainFrontiers Jun 2019 - Jan 2024Lausanne, Vaud, ChShepherd manuscripts through the peer review process, offering guidance to manuscript authors and the editorial board.
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Chief Ethics And Compliance OfficerEquideum Health Aug 2023 - Feb 2024Washington, Dc, Us❋ Served as a Consultant for a multi-million-dollar pediatric mental health research grant. Recommended research design principles and performed research regulatory gap analyses to address appropriate state, and federal mental health privacy, security, and research data integrity requirements.❋ Developed and implemented software ethical AI framework for the software development life cycle. -
Chief Scientific OfficerBurstiq Dec 2019 - Aug 2023Englewood, Colorado, Us❋ Spearheaded operations of the Life Sciences division, directing a variety of complex Web3-based software projects for clinical research and electronic health record systems.❋ Provided business development and research support for the company’s LifeGraph© solution, an innovative blockchain-based graph model software designed for healthcare, education, and life sciences organizations.❋ Guided a physician-led client by translating medical data capture concepts into functional requirements for the engineering team, creating a functional demo to showcase a proposal for enhanced interoperability.❋ Performed market intelligence, captured industry trends, and partnered with the marketing and product team to design and market software products for life sciences clients. -
Research Compliance Manager, Enterprise Compliance ServicesDenver Health Sep 2018 - Nov 2019Denver, Co, Us❋ Promoted to positions of increasing authority and responsibility due to exemplary performance and management. ❋ Oversaw the regulatory compliance of research conducted at this academic medical center.❋ Managed the institutions’ conflict of interest declaration and submission process.❋ Conducted research compliance risk assessments as part of the corporate compliance plan while also developing key risk mitigation plans and educational materials for critical research projects.❋ Received, investigated, and tracked research compliance issues related to export control, intellectual property, and investigational drugs and devices. -
Operations Manager, Research Department, Rocky Mountain Poison & Drug CenterDenver Health Jul 2016 - Sep 2018Denver, Co, Us❋ Designed and conducted extensive research in digital health usability and user experience, performing data collection, statistical analyses, and manuscript writing to optimize research outcomes. ❋ Served as Product Owner for the end-to-end development and design of digital health software projects and database structures, producing a well-functioning app, two usability research studies, and two publications.❋ Drove strict regulatory compliance and quality assurance for drug and device research by conducting thorough audits, reviewing IND submissions, and collaborating closely with regulatory agencies.
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Business / Pharmacovigilance Manager, Research Department, Rocky Mountain Poison & Drug CenterDenver Health Nov 2014 - Jul 2016Denver, Co, Us❋ Managed Pharmacovigilance division staff members and operations for post-market drugs and devices while monitoring for maximized productivity and efficiency. ❋ Implemented an ARISg global pharmacovigilance data system and facilitated integration with the FDA Electronic Submissions Gateway.❋ Created all documents for the pharmacovigilance regulatory documentation infrastructure with no findings/recommendations from a multi-day internal regulatory audit.
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Director, Research Regulatory AffairsNational Jewish Health Nov 2008 - Sep 2014Denver, Co - Colorado, UsResponsible for the regulatory compliance for all human and animal research in this Academic Medical Center:❋ Managed Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) staff, operations, and review of research❋ Reorganized workflows and performed cross-training of IRB staff positions, resulting in an average of 40.8% reduction in turnaround times for all types of reviews❋ Transitioned the IRB and IACUC committees to electronic review in 2012, resulting in cost savings between $20k and 25k per year❋ Advised researchers on compliant use of electronic technologies in clinical research, including electronic consent with tablets, electronic diaries, GPS tracking, and internet research❋ Directed the IRB through 2 successful FDA audits (2009 & 2014) with No Actions Indicated -
DirectorUrology Research Options May 2005 - Dec 2008❋ Spearheaded operations of the research center conducting urology and internal medicine trials, including managing phase II-IV FDA-regulated pharmaceutical and device trials.❋ Directed operations and resources for 85 commercially sponsored research studies, achieving an enrollment-to-quota ratio of 105%.❋ Implemented Clinical Trial Management Software, transitioning to enter all research subject visits electronically within 6 months.
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Institutional Research Review Board ManagerRose Medical Center 2002 - 2004❋ Created and launched an institutional infrastructure for HIPAA research compliance.❋ Performed all expedited and exempt reviews of new submissions and amendments and conducted intensive site audits for protocol and regulatory compliance.❋ Provided engaging presentations and training on ethics and human subject protections for investigators.
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Clinical Research ConsultantStark Smo 2002 - 2004❋ Assembled new research sites by training investigators and coordinators, including writing SOPs and assisting sites with regulatory document preparation and IRB submissions.❋ Performed extensive auditing and coaching for improved protocol and regulatory compliance.❋ Edited protocols and informed consent documents for investigator-initiated research and research
Wendy Charles, Phd Skills
Wendy Charles, Phd Education Details
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University Of Colorado Anschutz Medical CampusClinical Science With A Specialty In Health Information Technology -
The University Of MemphisPsychology With Emphasis In Neuropsychology
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University Of Colorado BoulderPsychology With An Emphasis In Neuroscience
Frequently Asked Questions about Wendy Charles, Phd
What company does Wendy Charles, Phd work for?
Wendy Charles, Phd works for College Of Professional Studies At University Of Denver
What is Wendy Charles, Phd's role at the current company?
Wendy Charles, Phd's current role is Teaching Assistant Professor.
What is Wendy Charles, Phd's email address?
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What is Wendy Charles, Phd's direct phone number?
Wendy Charles, Phd's direct phone number is +130373*****
What schools did Wendy Charles, Phd attend?
Wendy Charles, Phd attended University Of Colorado Anschutz Medical Campus, The University Of Memphis, University Of Colorado Boulder.
What are some of Wendy Charles, Phd's interests?
Wendy Charles, Phd has interest in Collecting Antique Maps And Manuscripts.
What skills is Wendy Charles, Phd known for?
Wendy Charles, Phd has skills like Clinical Trials, Clinical Research, Regulatory Affairs, Healthcare, Research, Oncology, Protocol, Fda, Hospitals, Life Sciences, Pharmaceutical Industry, Neuroscience.
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