Senior Clinical Trial Manager

• Oct 2020 - Present

Senior Clinical Trial Manager, Consultant

• Jun 2019 - Jan 2023

Coordinate with Zoe in clinical trial towards commercial product (app) Coordinate with Zoe in clinical trial towards commercial product (app)

Clinical Research Manager II

• Sep 2018 - Oct 2020

Develops and oversees the implementation of best practice guidelines for conducting clinical research protocols. Collaborates with Principal Investigators and study stakeholders for management of research studies. Manages and trains the activities of research staff and conducts Performance Management process. Prepares and monitors clinical laboratory and budgets, and ensures compliance with hospital and governmental regulations. Develops and oversees the implementation of best practice guidelines for conducting clinical research protocols. Collaborates with Principal Investigators and study stakeholders for management of research studies. Manages and trains the activities of research staff and conducts Performance Management process. Prepares and monitors clinical laboratory and budgets, and ensures compliance with hospital and governmental regulations.

Consultant

• Sep 2009 - Nov 2018

Review menus for nutritional adequacy and provides recommendations for changes based on federal dietary guidelines for Pine Street Inn clients Review menus for nutritional adequacy and provides recommendations for changes based on federal dietary guidelines for Pine Street Inn clients

Director of Clinical Operations, Nutrition Research

• Apr 2012 - Aug 2018

Coordinates and monitors clinical operations with physicians, investigators, study staff, nurses, lab technicians, pharmacists, patient care technicians, study subjects, and administrative staff Provides evidence-based expertise, project management, and leadership to investigators through all phases of study (design, implementation, oversight, compliance, data collection, and data analysis) of CCI and CTSU clinical study protocols Coordinates and monitors clinical operations with physicians, investigators, study staff, nurses, lab technicians, pharmacists, patient care technicians, study subjects, and administrative staff Provides evidence-based expertise, project management, and leadership to investigators through all phases of study (design, implementation, oversight, compliance, data collection, and data analysis) of CCI and CTSU clinical study protocols

Senior Research Dietitian

• Oct 2006 - Apr 2012

Initiated, developed and implemented data collection forms, and compliance tracking Educated and evaluated study volunteers on protocol specifics to optimize compliance Initiated, developed and implemented data collection forms, and compliance tracking Educated and evaluated study volunteers on protocol specifics to optimize compliance

Research Dietitian and Clinical Study Coordinator

• Jun 2002 - Oct 2006

Customized research methods for data collection and analysis in multi-center NIH clinical trials study Monitored patient data for quality and accuracy to ensure patient safety and study parameters adherence Customized research methods for data collection and analysis in multi-center NIH clinical trials study Monitored patient data for quality and accuracy to ensure patient safety and study parameters adherence

Consultant

• Apr 2005 - May 2006

Developed dietary-related research intervention to optimize Phase II trial of obesity drug protocol Managed onsite study monitoring and data collection at Phase I/II CRO Developed dietary-related research intervention to optimize Phase II trial of obesity drug protocol Managed onsite study monitoring and data collection at Phase I/II CRO