Clinical Trial Manager

• Feb 2022 - Present

Study Management Associate III

• Oct 2021 - Feb 2022

Clinical Research Associate II

• Dec 2019 - Oct 2021

Organization, management an execution of projects to ensure clinical trials are conducted, recorded and reported in accordance with the protocol, standard operating procedures, and applicable global, local and regulatory requirements. Support and conduct accompanied site qualification, initiation, interim monitoring and study closeout visits for phase 1-4 clinical trials. Responsible for conducting assigned clinical site activities and supporting the senior CRA in those, according to the monitoring plan in accordance with the study timelines and company objectives. Continuously ensuring quality data, timely submission and appropriate reporting for all clinical trial activities Show less

CRA II Syneos Health on Assignment with AbbVie, Inc.

• Jun 2018 - Dec 2019

Organization, management an execution of projects to ensure clinical trials are conducted, recorded and reported in accordance with the protocol, standard operating procedures, and applicable global, local and regulatory requirements. Support and conduct accompanied site qualification, initiation, interim monitoring and study closeout visits for phase 1-4 clinical trials. Responsible for conducting assigned clinical site activities and supporting the senior CRA in those, according to the monitoring plan in accordance with the study timelines and company objectives. Continuously ensuring quality data, timely submission and appropriate reporting for all clinical trial activities. Show less

Certified Clinical Research Coordinator

• Jun 2013 - Jun 2018

Using fine attention to detail, superior organizational skills and excellent time management to ensure all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines and good clinical practice. Responsibilities including registration and continuous following of patients as they continue on study and after study completion, managing data as related are carried out meticulously and professionally. Scheduling and participate in monitoring visits, acting as a representative for Karmanos. Assisting in creation of protocols, database systems and policy making. Serving as a consultant to faculty and support staff. Prioritizing each task appropriately, analyzing problems and effect resolutions, maintenance of cooperative working relationships with internal and external units in a clinical research environment. Training and mentorship of new employees, designing orientation modules and training materials. Active member of multiple policy making committees, taking a leadership role in perfecting practices and creating guidelines. Show less

Research Assistant

• Sep 2010 - Aug 2012

Developed lab specific coding guide for Joint Attention study, including meticulous system for data coding and complete a fully functioning database. Assist with the design and production of posters, and presentations, which went on to win first and second place university departmental awards. Extensive use of SPSS software, PowerPoint, Excel and Word. Trained and supervised new undergraduate research assistants, guiding, mentoring and advising. Developed lab specific coding guide for Joint Attention study, including meticulous system for data coding and complete a fully functioning database. Assist with the design and production of posters, and presentations, which went on to win first and second place university departmental awards. Extensive use of SPSS software, PowerPoint, Excel and Word. Trained and supervised new undergraduate research assistants, guiding, mentoring and advising.

Undergraduate Research Assistant

• Sep 2011 - Jan 2012

Under limited supervision studied and coded parent-child social interaction in instances of pediatric cancer treatment. Independently reviewed recordings of patient treatment and assigned proper scores based on four point coding scale and in-put data into Excel. Under limited supervision studied and coded parent-child social interaction in instances of pediatric cancer treatment. Independently reviewed recordings of patient treatment and assigned proper scores based on four point coding scale and in-put data into Excel.