Experience

Spaulding Clinical Research, LLC

• United States
• Research Services
• 100 - 200 Employee

• Associate Study Manager

  • Oct 2021 - Present

  • Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards• Maintains professional working relationships with Sponsor representatives and internal colleagues• Manages monitoring activities by maintaining regulatory binders, hosting monitoring visits, and query resolution• Assists with writing startup plans and overseeing protocol compliance during study, as well as maintaining accurate records of all protocol activities and events• Contributes to excellent communication and risk mitigation on each project by creating communication plans, data reconciliation plans and protocol deviation logs for review• Identifies and creates training package needs including study specific training and PowerPoint slides and specialty training for clinical staff• Writes Informed Consent Form (ICF)• Reviews Investigational Drug Brochures, Protocol, Case Report Forms, and informed consent forms for a thorough understanding of study drug and procedures• Designs databases in accordance with project specifications and checks systems through standardized testing approaches• Protects data integrity through regular quality checks and accuracy validation, identifying and resolving problems proactively

• EMT/ Clinical Research Technician- Advanced

  • Aug 2020 - Oct 2021



Jackson Fire Department

• Firefighter/EMT

  • Jul 2020 - Present



Greystar

• United States
• Real Estate
• 700 & Above Employee

• Community Assistant

  • Nov 2017 - Jun 2019



Spaulding Clinical Research, LLC

• United States
• Research Services
• 100 - 200 Employee

• Clinical Research Sample Specialist

  • Jun 2014 - Jun 2018