Grace Batcha
Regulatory Affairs Coordinator at University of Colorado Anschutz Medical Campus- Claim this Profile
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Bio
Credentials
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Accessing Your Brain’s Hidden Potential
LinkedInJul, 2022- Oct, 2024 -
Crucial Conversations (getAbstract Summary)
LinkedInJul, 2022- Oct, 2024 -
How to Crush Self-Doubt and Build Self-Confidence
LinkedInJul, 2022- Oct, 2024 -
Overcome Overthinking
LinkedInJul, 2022- Oct, 2024 -
Strategies for Your First 90 Days in a New Job
LinkedInJul, 2022- Oct, 2024 -
CITI Health Information Privacy and Security (HIPS) for Clinical Investigators
CITI ProgramJun, 2021- Oct, 2024 -
Adverse Events & Safety
TransCelerate BioPharma Inc.Apr, 2021- Oct, 2024 -
Monitoring and Auditing
TransCelerate BioPharma Inc.Apr, 2021- Oct, 2024 -
Investigational Product
TransCelerate BioPharma Inc.Mar, 2021- Oct, 2024 -
Medidata Rave EDC: Clinical Research Coordinators
Medidata SolutionsMar, 2021- Oct, 2024 -
Medidata Rave EDC: Getting Started
Medidata SolutionsMar, 2021- Oct, 2024 -
Source Documentation
TransCelerate BioPharma Inc.Mar, 2021- Oct, 2024 -
iMedidata Account Management
Medidata SolutionsMar, 2021- Oct, 2024 -
Essential Documents
TransCelerate BioPharma Inc.Feb, 2021- Oct, 2024 -
IRB/IEC Responsibilities & Informed Consent
TransCelerate BioPharma Inc.Feb, 2021- Oct, 2024 -
Clinical Practice vs Clinical Research
TransCelerate BioPharma Inc.Jan, 2021- Oct, 2024 -
Investigator Oversight Informational Program
TransCelerate BioPharma Inc.Oct, 2020- Oct, 2024 -
CITI Good Clinical Practice Course
CITI ProgramJun, 2021- Oct, 2024 -
Institutional/Signatory Official: Human Subject Research
CITI ProgramJun, 2021- Oct, 2024 -
Phlebotomy Technician (PBT)
National Phlebotomy Certification TestingJun, 2021- Oct, 2024 -
Study Coordinators/Key Research Staff (Biomedical)
CITI ProgramJun, 2021- Oct, 2024 -
Member of the Association of Clinical Research Professionals
Association of Clinical Research ProfessionalsApr, 2020- Oct, 2024 -
Emergency and Incident Response to Biohazard Spills and Releases
CITI ProgramJul, 2021- Oct, 2024 -
Basic Introduction to Biosafety
CITI ProgramJun, 2021- Oct, 2024 -
OSHA Bloodborne Pathogens
CITI ProgramJun, 2021- Oct, 2024 -
Personal Protective Equipment
CITI ProgramJun, 2021- Oct, 2024 -
Shipping and Transport of Regulated Biological Materials
CITI ProgramJun, 2021- Oct, 2024
Experience
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University of Colorado Anschutz Medical Campus
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United States
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Higher Education
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700 & Above Employee
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Regulatory Affairs Coordinator
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Jun 2022 - Present
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Paradigm Clinical Research Centers, Inc.
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United States
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Research Services
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1 - 100 Employee
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Clinical Research Coordinator
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Oct 2021 - Jun 2022
Execute knowledge of ICH and FDA regulations regarding Good Clinical Practice Creation and modification of source documents which actively reflect study protocol
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Data Entry Coordinator
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Jun 2021 - Nov 2021
Ensured quality of data, timely data entry and query resolution Performed laboratory and phlebotomy procedures for data retrievalDesigned and submitted original research study advertisements to the IRB
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Space Assistant
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Feb 2020 - May 2021
Coordinated employee training and created multimedia resources for best practicesPerform audits on campus office space to verify space usage and ensure accuracy of records and databasesManage and translate building codes from blueprints into AiM database Coordinated employee training and created multimedia resources for best practicesPerform audits on campus office space to verify space usage and ensure accuracy of records and databasesManage and translate building codes from blueprints into AiM database
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YMCA of the USA (National Resource Office)
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United States
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Non-profit Organizations
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700 & Above Employee
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Camp Counselor
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Jun 2019 - Aug 2019
Ensured safety and well-being of faculty and campersFacilitated positive relationships with families, coworkers, and campers Ensured safety and well-being of faculty and campersFacilitated positive relationships with families, coworkers, and campers
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Education
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University of North Carolina Wilmington
Bachelor's degree, Clinical/Medical Laboratory Science/Research and Allied Professions