Senior Clinical Trial Associate

• Jul 2021 - Present

Create and execute project work plans and revises as appropriate to meet changing needs and requirements. Manages day-to-day operational aspects of a project and scope Create and execute project work plans and revises as appropriate to meet changing needs and requirements. Manages day-to-day operational aspects of a project and scope

Clinical Trial Associate

• Oct 2019 - Jul 2021

Create, maintain and/or close out project files and study information (e.g., regulatory documents, Trail Master File (TMF), enrollment, Adverse Events (AEs)/ Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems. Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues. Create, maintain and/or close out project files and study information (e.g., regulatory documents, Trail Master File (TMF), enrollment, Adverse Events (AEs)/ Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems. Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.

Clinical Research Assistant

• Jan 2019 - Oct 2019

Perform the screening, recruiting, and obtaining consent of study participants. Review medical records and/or perform telephone or in-person interviews. Perform basic measurements and tests on patients according to protocol, such as obtaining vital signs, EKG, Fibro-scan and performing phlebotomy. Perform the screening, recruiting, and obtaining consent of study participants. Review medical records and/or perform telephone or in-person interviews. Perform basic measurements and tests on patients according to protocol, such as obtaining vital signs, EKG, Fibro-scan and performing phlebotomy.

Clinical Trial Assistant

• Jun 2016 - Jan 2019

Developed and maintained filing structure (TMF\eTMF) for all active studies that resulted in 100% compliance according to industry standards. Lead/trained teams on TMF/eTMF and how to maintain compliance according to "Good Documentation Practices". Developed and maintained filing structure (TMF\eTMF) for all active studies that resulted in 100% compliance according to industry standards. Lead/trained teams on TMF/eTMF and how to maintain compliance according to "Good Documentation Practices".

Loan Closer

• Oct 2015 - Jun 2016

Teller

• Mar 2015 - Oct 2015

Sales Associate

• Aug 2014 - Mar 2015