Madisyn Edwards
Indianapolis
Summary
Experienced life sciences professional specializing in biospecimen management within regulated laboratory environments. Proven success supporting clinical research projects through meticulous specimen handling, data reporting and QC, and cross-functional collaboration. Eager to utilize my skills in sample lifecycle management to support clinical development at Lilly. Dedicated to advancing patient-centered research and contributing to Lilly's mission of improving lives through innovation and scientific excellence.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Indiana University Health
07.2023 - Current
- Coordinates implementation and execution of biorepository research projects, including screening and enrollment of participants, accurately documenting clinical data, and ensuring proper storage and integrity of biological specimens
- Performs accurate data entry and maintains database management system of over 30,000 samples
- Collaborates with cross-functional teams, including CROs, investigators, physicians, and study coordinators, to ensure successful coordination of research specimens
- Provides leadership and direct supervision to biorepository team, including onboarding, training and mentoring of new personnel
- Ensures highest quality research standards are met by expertly maintaining Good Clinical Practices (GCP) and Standard Operating Procedures (SOP)
Biorepository Research Assistant
Indiana University Health
08.2021 - 07.2023
- Responsible for biorepository sample collection, storage, distribution and shipping.
- Verified clinical data and supporting material is properly uploaded to sample management system
- Reviewed sample reports and identifies specimens requiring issue resolution
Pasteurization Technician
The Milk Bank
10.2019 - 08.2021
- Managed collection, processing, storage and distribution of donated breastmilk according to current Good Manufacturing Procedures (GMP)
- Operated and monitored pasteurization equipment to ensure proper temperature and processing times
- Implemented and maintained quality control processes to ensure safety and compliance with FDA regulations
- Calibrated instruments to maintain required productivity levels and adherence to quality standards
Education
Bachelor of Science - Biology
Purdue University
Indianapolis, IN05.2020
Skills
- Sample lifecycle management
- Protocol development
- Data reporting and analysis
- LIMS utilization
- Pre-analytical sample processing
- Regulatory requirements (eg, GCP, FDA, IRB)
Certification
Biomedical Researcher, Collaborative Institutional Training Initiative, 2023
Timeline
Clinical Research Coordinator
Indiana University Health
07.2023 - Current
Biorepository Research Assistant
Indiana University Health
08.2021 - 07.2023
Pasteurization Technician
The Milk Bank
10.2019 - 08.2021
Bachelor of Science - Biology
Purdue University
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