Lindsey Hacherl
Buffalo,NY
Summary
Seasoned clinical trial professional with a robust background in biological sciences and hands-on clinical experience, ready to leverage comprehensive knowledge of clinical research in a dynamic new role. Driven by a passion for scientific advancement and its potential to improve patient outcomes, I am eager to contribute significantly to this mission. Demonstrated ability to manage multiple projects efficiently, while collaborating effectively with clinical teams, institutional review boards, and clinical research organizations to ensure timely and high-quality study execution.
Overview
7
7
years of professional experience
Work History
Regulatory Affairs Specialist
Circuit Clinical
01.2022 - Current
- Maintenance of regulatory documentation for FDA and GCP compliance across various sites, studies, sponsors, and networks, ensuring accuracy and adherence to standards.
- Ensured regulatory documentation met all network Standard Operating Procedures (SOPs) for format and content, maintaining high levels of compliance and quality.
- Managed and updated study credentials for all study staff and sites, ensuring up-to-date and compliant documentation.
- Coordinated and updated protocol and consent form amendments in line with Institutional Review Board (IRB) policies and SOPs; organized, processed, and submitted IRB documentation for clinical trials.
- Prepared and submitted Investigational New Drug Safety Reports as directed by the Principal Investigator (PI), ensuring timely and accurate reporting to the IRB in accordance with protocol requirements.
- Supported internal and external audit teams by addressing regulatory-related issues, ensuring a smooth audit process and compliance with regulatory standards.
- Collaborated with research coordinators to identify, manage, and resolve regulatory issues throughout the trial lifecycle, enhancing operational efficiency and compliance.
- Maintained regular communication with the Regulatory Team to address and resolve study and site-specific regulatory issues, ensuring effective guidance and follow-through.
- Archived all study-specific regulatory documentation and correspondence systematically, ensuring easy retrieval and long-term preservation.
- Participated in network meetings, conference calls, and monthly staff meetings to stay informed on regulatory updates and contribute to team discussions.
Regulatory Research Coordinator
Roswell Park Comprehensive Cancer Center
01.2020 - 01.2022
Research Associate
Roswell Park Comprehensive Cancer Center
08.2019 - 01.2020
Emergency Department Medical Scribe
Mercy Hospital Of Buffalo
06.2017 - 08.2018
Education
Master of Arts - Biological Sciences
University At Buffalo
Buffalo, NY12.2024
Post-Baccalaureate Certificate - Medicine
Lake Erie College of Osteopathic Medicine
Erie, PA04.2019
Bachelor of Arts - Biology
State University of New York College At Geneseo
Geneseo, NY05.2017
Skills
- Project Management
- Clinical Research
- Microsoft Office
- Medical Terminology
- Client Relations
- Communication
- Creative Solutions
Timeline
Regulatory Affairs Specialist
Circuit Clinical
01.2022 - Current
Regulatory Research Coordinator
Roswell Park Comprehensive Cancer Center
01.2020 - 01.2022
Research Associate
Roswell Park Comprehensive Cancer Center
08.2019 - 01.2020
Emergency Department Medical Scribe
Mercy Hospital Of Buffalo
06.2017 - 08.2018
Master of Arts - Biological Sciences
University At Buffalo
Post-Baccalaureate Certificate - Medicine
Lake Erie College of Osteopathic Medicine
Bachelor of Arts - Biology
State University of New York College At Geneseo
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