Summary
Overview
Work History
Education
Skills
Timeline
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Hannah Kreinbrink

Summary

A Clinical Research professional with advanced expertise in clinical trial coordination, regulations, and start-up processes. Demonstrates a profound commitment to advancing neuroscience research methodologies, integrating extensive industry experience with rigorous academic training. Known for a strategic and visionary approach, consistently driving innovations in clinical trial processes that adhere to the highest standards of Good Clinical Practice (GCP) across all phases, from registry to phase I. Exhibits a methodical and enterprising intellect, adept at developing and implementing research strategies that prioritize precision, ethical integrity, and operational excellence. Proven ability to navigate complex scientific and regulatory challenges, contributing to the success and impact of diverse research initiatives.

Overview

9
9
years of professional experience

Work History

Neuroscience Graduate Researcher

Wake Forest School Of Medicine
09.2023 - Current
  • Prepared reports summarizing research findings and recommendations.
  • Developed methods for collecting primary data through surveys, interviews, focus groups.
  • Performed literature reviews to identify current trends in the field of research.
  • Compiled feedback from internal stakeholders regarding project progress.
  • Created visualizations of complex datasets using software such as Tableau or Excel.
  • Reviewed manuscripts submitted for publication in academic journals.
  • Developed models for predicting outcomes based on the data collected.

Clinical Research Analyst

Swedish Neuroscience Institute
08.2020 - Current
  • Work with principal investigator and sponsors to facilitate daily trial activities and comply with complex research protocols with interventional, device, registry, and investigator-initiated trials
  • Assist Heart & Vascular alongside Neuroscience research departments with study start up activities such as: maintaining/collecting essential documents in an eBinder system(Florence), submission of new studies to local & central IRB(s), acting as primary regulatory contact for +15 studies at one time, processing continuing reviews, processing amendments and facilitating relevant training to all personnel
  • Collected data and followed research protocols, operations manuals, and case report form requirements
  • Edited and helped publish articles for the spine clinical research fellows to be published in The Spine Journal
  • Maintained compliance with protocols covering patient care and clinical trial operations
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
  • Gathered, processed, and shipped lab specimens (IATA certified)
  • Collected, evaluated and modeled collected data using EPIC SlicerDicer
  • Appointed to present and educate other research staff on the functionality and efficacy of tool in day-to-day operations and identifying candidates in the hospital that would qualify for complex clinical trials
  • Coordinated clinical trials focused on disorders such as Subdural Hematoma, COVID-19, Acute Ischemic Stroke and Amyotrophic Lateral Sclerosis(ALS)
  • Certified to conduct: Neurocognitive Battery test, Modified Rankin Scale (mRS), Mini-Mental State Exam (MMSE), the Multiple Sclerosis Functional Composite (MSFC), Columbia Suicide Severity Rating (CSSR-S) with research subjects

Clinical Research Coordinator

Swedish Neuroscience Institute
06.2022 - 08.2024
  • Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
  • Collaborated with internal departments such as Regulatory Affairs and Data Management to ensure that all studies were conducted in accordance with ICH-GCP guidelines.
  • Reviewed CRFs for completeness and accuracy before database entry.
  • Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
  • Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
  • Took vital signs and collected medical histories as part of study protocols.
  • Conducted screening interviews to determine eligibility of possible subjects.
  • Educated participants on studies and anticipated outcomes.
  • Placed orders for medications to be used in studies.

clinical research coordinator

benaroya research institute
09.2019 - 08.2020
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols for interventional trials Phase I-IV in areas of neuroendocrine, urothelial carcinoma, prostate cancer, and gastrointestinal oncology trials as primary coordinator
  • SIV, SQV, audit preparation, and monitor visit facilitation
  • Collection of AEs, SUSARS, and processing protocol deviations
  • Phlebotomy, vital collection and specimen processing(MA-R and MA-P certified)
  • Drafting consents and protocols for PIs and Sub-Is in investigator-initiated trials
  • Experience operating with RAVE, CTMS and CTEP platforms
  • Collected data and followed research protocols, operations manuals, and case report form requirements
  • Prepared and submitted regulatory file applications and supporting documentation to the appropriate IRB

Science Contributor Content Writer

Naturopathic Doctor News & Review
08.2018 - 08.2019
  • Wrote and edited high-quality content and visually impactful programs under deadline pressure with exciting, captivating and authentic approach bridging cardiology, immunology and neuroscience
  • Completed thorough research into assigned topics in order to produce 5,000 words per week of publishable content
  • Utilized exceptional writing, editing and proofreading skills to produce engaging and error-free content
  • Provided writing support in fast-paced environment for variety of public-facing materials

Research Assistant

Visual perception laboratory with Dr. Peterson
08.2015 - 12.2017
  • Recorded data and maintained source documentation following good documentation practices
  • Assisted faculty members with research assignments on graduate-level visual perception psychology projects
  • Planned, modified, and executed research techniques, procedures and tests including ERPs, fMRI, and behavioral methods to investigate how unconcsicously activated knowledge affects attention and perception
  • Worked both independently and collaboratively in a fast-paced laboratory environment
  • Created figure-ground perception stimuli using Adobe and PhotoShop
  • Consent participants to research studies
  • Administered visual acuity tests, and collected data using a variety of visual perception tools such as eyetracker, ocular devices for tracking eye movement., and troubleshooting programming(Python & MatLab) on certain implemented tests.

Research Assitant

Neuroscience of Reinforcement learning laboratroy with Dr. Wilson
08.2016 - 02.2017
  • Worked both independently and collaboratively in fast-paced laboratory environment
  • Performed EEG tests on research subjects to support rotating graduate students
  • Performed statistical, qualitative and quantitative analysis
  • Help create a boot camp curriculum for programming(MatLab) for high school students
  • Outreach to high school students to educate about the neuroscience & cognitive science program at the University of Arizona and an introduction to programming
  • Attended seminars and symposiums to improve overall knowledge and understanding
  • Gathered, arranged and corrected research data to create representative graphs and charts highlighting results for presentations

Research Specialist

Center For Neurosciences
  • Offered full-time employment upon completion of two week internship
  • Assisted with recruitment of research participants with focus on fostering internal clinic relationships
  • Analyzed variations in complex tests, experiments and procedures to produce research data
  • MMSE rater within the clinic

Education

NEUROSCIENCE (MS) -

WAKE FOREST UNIVERSITY
08.2024

Neuroscience and Cognitive Science (BS) - memory

University of arizona
12.2017

clinical research fastrack phoenix, Az

Tucson high magnet school tucson, az

Skills

  • Clinical Research
  • Good Clinical Practice (GCP)
  • Data Analysis
  • Public Presentations
  • Analytical Thinking
  • Task Prioritization
  • Problem-Solving
  • Statistical Analysis
  • Predictive Modeling
  • Support Vector Machines
  • Random Forests
  • Logistic Regression
  • Neuroimaging Techniques
  • Voxel-Based Morphometry
  • Matlab SPM Platform
  • Big Data Analysis
  • R Programming
  • Leadership
  • Regulatory Compliance
  • Data Collection
  • Case Report Form (CRF) Requirements
  • Article Editing and Publishing
  • Patient Screening
  • Lab Specimen Processing
  • EPIC SlicerDicer
  • Clinical Trial Coordination
  • Neurocognitive Battery Test
  • Phlebotomy
  • Protocol Deviations
  • Regulatory File Applications
  • Content Writing
  • Research Specialist
  • Recruitment
  • MMSE Rater
  • Visual Perception
  • ERPs
  • FMRI
  • Behavioral Methods
  • Adobe Photoshop
  • Consent Administration
  • Visual Acuity Tests
  • Eye Tracking
  • Programming (Python & Matlab)
  • EEG Testing
  • Qualitative and Quantitative Analysis
  • Curriculum Development
  • Outreach
  • Seminar and Symposium Attendance
  • Data Visualization

Timeline

Neuroscience Graduate Researcher

Wake Forest School Of Medicine
09.2023 - Current

Clinical Research Coordinator

Swedish Neuroscience Institute
06.2022 - 08.2024

Clinical Research Analyst

Swedish Neuroscience Institute
08.2020 - Current

clinical research coordinator

benaroya research institute
09.2019 - 08.2020

Science Contributor Content Writer

Naturopathic Doctor News & Review
08.2018 - 08.2019

Research Assitant

Neuroscience of Reinforcement learning laboratroy with Dr. Wilson
08.2016 - 02.2017

Research Assistant

Visual perception laboratory with Dr. Peterson
08.2015 - 12.2017

Research Specialist

Center For Neurosciences

NEUROSCIENCE (MS) -

WAKE FOREST UNIVERSITY

Neuroscience and Cognitive Science (BS) - memory

University of arizona

clinical research fastrack phoenix, Az

Tucson high magnet school tucson, az
Hannah Kreinbrink