Amiryn Klose
Bradenton,FL
Summary
Clinical Research Associate with 10 years’ experience who is driven and adaptable professional adept at coordinating multiple projects concurrently with accuracy, maintaining a constant commitment to organization, discipline, and goal attainment. Thrives in high-pressure environments, consistently utilizing positivity, focus, and enthusiasm to drive success.
Overview
12
12
years of professional experience
Work History
Clinical Research Associate
CRA Solutions
08.2021 - 03.2024
- Conduct site qualification and initiation visits
- Complete on-site and remote monitoring activities
- Ensure study site compliance with protocol, regulations and GCP
- Review source data to verify it is accurately captured on the CRF/eCRFs
- Review the completeness and accuracy of site and Sponsor regulatory files
- Ensure all adverse events are reported per protocol and regulatory requirements
- Verify and ensure the accuracy of product accountability
- Complete monitoring reports and associated letters
- Track and manage action items and queries to resolution.
Owner/Operator
Savvy Juice
01.2018 - 12.2020
Clinical Research Associate
D&K CTMC Consultants
01.2012 - 12.2016
- Project and site management
- Managed essential documents as required by Sponsor SOP and regulatory requirements before, during, and after a clinical study
- Conducted Qualification, Initiation, Monitoring and Closeout Visits
- Ensure data integrity and study is conducted in compliance with approved protocol, GCP, applicable regulations, and internal SOPs
- Ensured study site compliance with protocol, regulations and GCP
- Maintained required regulatory documents for master file and site files
- Participated in study start-up activities to include case report form development, protocol development, monitoring plan development, data collection tools and study templates
- Ensured all adverse events were reported per protocol and regulatory requirements
- Reviewed source data to verify data was accurately captured in the Case Report Form
- Confirmed site maintained accurate essential regulatory documents
- Verified and ensured the accuracy of product accountability
- Completed monitoring reports and associated visit letters
- Tracked and managed action items and queries to resolution
- Trained CRAs and study site staff personnel
- Reviewed monitoring reports of other CRAs
- Identified and resolved study enrollment and progression barriers.
Education
Bachelor of Arts - Human Resources Management
Jasper University
Skills
- Type 96WPM
- Proficient with project management software
- Team player
- Excellent time management skills
- Conflict management
- Public speaking
- Data analytics
Activities
- Literature
- Environmental conservation
- Art
- Yoga
- Skiing
- Travel
Additional Information
food service
Timeline
Clinical Research Associate
CRA Solutions
08.2021 - 03.2024
Owner/Operator
Savvy Juice
01.2018 - 12.2020
Clinical Research Associate
D&K CTMC Consultants
01.2012 - 12.2016
Bachelor of Arts - Human Resources Management
Jasper University
Similar Profiles
Noreen RathgeberNoreen Rathgeber
Clinical Research Associate at CRA Solutions, Inc.Clinical Research Associate at CRA Solutions, Inc.
Kevin CostaKevin Costa
GSP (General Support Person) at CRA (Correctional Recovery Academy)GSP (General Support Person) at CRA (Correctional Recovery Academy)
Fenomanana MoroyandsaFenomanana Moroyandsa
Remote Clinical Research Associate, CRC, Intern at International Clinical Research Academy “CRA School”Remote Clinical Research Associate, CRC, Intern at International Clinical Research Academy “CRA School”
Celine BattsCeline Batts
Customer Service Cashier at Cracker BarrellCustomer Service Cashier at Cracker Barrell
LISA WEINGARTNERLISA WEINGARTNER
General Manager, Global Diagnostics Business Division at VELSERAGeneral Manager, Global Diagnostics Business Division at VELSERA