Specialist, Clinical Research

• Mar 2021 - Present

Clinical Trials Manager

• Sep 2019 - Mar 2021

Clinical Project Specialist II

• Jul 2018 - Sep 2019

Clinical Project Specialist

• Sep 2017 - Jul 2018

Data Management Associate

• Apr 2015 - Sep 2017

Clinical Trials Assistant

• Jul 2014 - Apr 2015

Freelance Translator

• 2014 - Dec 2018

Clinical Trial Specialist II

• Jun 2012 - Dec 2013

Associate Site Start Up Specialist

• Jan 2010 - May 2012

Key Responsibilities:Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording andbudgets.• Resolve all site issues and report site status to SSU Lead.• Prepare and distribute internal documentation and reports to sites and project team members as needed.• Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.• Interact with regulatory team members or sponsor to secure authorization of regulatory documents.• Interact with legal or sponsor to secure authorization of regulatory documents.• Interact with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.• Inform team members of completion of regulatory and contractual documents for individual sites.• Work with team members in preparation of Independent Ethics Committees and Institutional Review Board submissions perwork instructions.

Study Coordinator

• Jul 2008 - Dec 2009

Key Responsibilities:Drug AccountabilityManage AE/ SAE’sQuery resolutionSubmission to ethics/IRB Key Responsibilities:Drug AccountabilityManage AE/ SAE’sQuery resolutionSubmission to ethics/IRB