Kerry Mcenaney Email & Phone Number

Boston, MA, US

Boston, MA, US

- Project Management of Data Coordinating Center for several multi-center IDE trials- Regulatory and Data Monitoring, including on-site and remote monitoring visits for FDA regulated IND/IDE trials, Drug and Device Accountability, as well as international site audits for QI project- On-site preparation and support during BIMO study-site audits- Study.

Boston, MA, US

- Provided project management and study oversight ensuring compliance with FDA and local IRB regulations - Performed Regulatory Monitoring and Drug and Device Accountability on multi-center FDA regulated trials- Performed interim remote Data Monitoring visits and generated query reports- Performed International on-site data monitoring for QI project.

Boston, MA, US

- Collected and entered data into EDC database for FDA regulated drug and device trials- Documented and reported AEs/SAEs, deviations, and violations to appropriate authorities- Prepared and maintained appropriate study regulatory documents including initial FDA and IRB approvals, amendments, and continuing renewals- Prepared data reports for and.

US

- Evaluated Anti-depressant Treatment Response Indicator (ATR) and Bispectral Index (BIS), a tool used to measure depth of anesthesia- Traveled to study sites to train site staff, audit site files, and collect raw data- Developed co-op Standard Operating Procedure Manual ensuring smooth transition of projects- Ensured regulatory files contained all.

US

- Carried out experimental protocols studying genetic variance in circadian rhythm, influence of extended wake-periods on cognitive agility and effect of light therapy on circadian rhythm in vision-impaired and blind subjects- Applied electrodes according to the International 10-20 system (EEG)- Obtained specimen samples- Acted as liaison between subjects.

Bs, Behavioral Neuroscience

Education record