Senior CRA

• May 2021 - Present

Senior CRA 3 at PRA

• Dec 2020 - May 2021

Sr. CRA 2

• May 2019 - Nov 2020

Contract Senior Clinical Research Associate

• Mar 2016 - Nov 2017

Assisted in training of sites and review of data collected for clinical trial for use of Traditional Chinese Medicine (TCM) product in the treatment of influenza for Yiling Pharmaceuticals. Conducted site management activities, including site initiation visits, site training, routine monitoring visits, and site close-out visits for pediatric meningitis vaccine trial. Conducted follow-up visits for long-term survival for an ongoing breast cancer study. Assisted in training of sites and review of data collected for clinical trial for use of Traditional Chinese Medicine (TCM) product in the treatment of influenza for Yiling Pharmaceuticals. Conducted site management activities, including site initiation visits, site training, routine monitoring visits, and site close-out visits for pediatric meningitis vaccine trial. Conducted follow-up visits for long-term survival for an ongoing breast cancer study.

Regulatory Document Manager

• Jan 2015 - Mar 2016

Collected, reviewed, and submitted regulatory documents on behalf of clinical trial sites for Boehringer-Ingelheim Pharmaceuticals per their SOPs, FDA regulations, and ICH-GCP guidelines during all phases of clinical trial conduct. Collected, reviewed, and submitted regulatory documents on behalf of clinical trial sites for Boehringer-Ingelheim Pharmaceuticals per their SOPs, FDA regulations, and ICH-GCP guidelines during all phases of clinical trial conduct.

Senior Clinical Research Associate

• Jan 2013 - Oct 2014

Field position conducting monitoring visits for start-up and interim unblinded monitoring visits for patients receiving investigative 2-dose Hepatitis B vaccine. Conducted site selection and monitoring visits for subjects receiving C. difficile vaccine Conducted follow-up visits for long-term survival for an ongoing breast cancer study. Field position conducting monitoring visits for start-up and interim unblinded monitoring visits for patients receiving investigative 2-dose Hepatitis B vaccine. Conducted site selection and monitoring visits for subjects receiving C. difficile vaccine Conducted follow-up visits for long-term survival for an ongoing breast cancer study.

Senior Clinical Research Associate on assignment with Sanofi Pasteur

• Jan 2011 - Jan 2013

Conducted site management activities, including but not limited to site selection visits, site initiation visit, site personnel training, routine monitoring visits, and site close-out visits. Ensured site compliance with protocols, SOPs, and ICH-GCP guidelines. Provided training and mentoring for new CRAs as assigned. Conducted site management activities, including but not limited to site selection visits, site initiation visit, site personnel training, routine monitoring visits, and site close-out visits. Ensured site compliance with protocols, SOPs, and ICH-GCP guidelines. Provided training and mentoring for new CRAs as assigned.

Clinical Research Coordinator

• Jan 2009 - Jan 2011

• Evaluated and recruited appropriate subjects for clinical trials. Performed clinical study procedures per protocol within RN scope of practice. Monitored and evaluated potential onset of adverse events in trial subjects. Provided quality assurance for study documents and coordinated entry of data into eCRF applications on a contract basis • Evaluated and recruited appropriate subjects for clinical trials. Performed clinical study procedures per protocol within RN scope of practice. Monitored and evaluated potential onset of adverse events in trial subjects. Provided quality assurance for study documents and coordinated entry of data into eCRF applications on a contract basis

Senior Clinical Research Associate and Trainer

• Jan 1999 - Jan 2009

Responsible for roll-out and support of new clinical trial management software for North American Biologics. Provided study template US-specific design for accurate recording of study progress Responsible for training and ongoing support for North American BIO Study managers, monitors, and CRO staff. Lean Sigma Expert and trainer - facilitated use of Lean Sigma methodology in assigned committees. Monitored clinical sites conducting pre-study visits, site initiation, periodic, and close-out monitoring visits. Ensured sites complied with protocols and GCP requirements. Show less

Clinical Research Nurse

• Jan 1997 - Jan 1999

Recruited appropriate subjects for studies and interacted with study subjects. Performed required clinical procedures within scope of practice. Coordinated all aspects of clinical research trials at two medical clinics. Recruited appropriate subjects for studies and interacted with study subjects. Performed required clinical procedures within scope of practice. Coordinated all aspects of clinical research trials at two medical clinics.