Chloe Hughes Email & Phone Number

South San Francisco, California, Us

● Oversees global operations for late stage drug development● Managed feasibility for multi-center global COPD study, ARNASA, with a focus on identifying trial sites with diverse patient populations● Develops global recruitment strategies for accelerated, high priority studies ● Hosts recruitment workshops for high priority study nationally to identify and address barriers to enrollment● Oversees multiple third party vendors and ensures accountability in spending

Mountain View, California, Us

● Developed project timelines and identified critical paths through coordination between different teams, including nonclinical, CMC, regulatory, and finance ● Coordinated study start up for first-in-human phase I global trials● Developed processes for change management and lessons learned review to continually improve department efficiency● Oversaw completion of all regular filings with FDA and relevant regulatory agencies

San Diego, Ca, Us

● Contributed to writing IND-enabling reports on behalf of sponsors ● Collaborated directly with clients and Sponsors to identify key project management timelines and goals● Provided crucial data for the creation of clinical development plans● Designs and implements experimental protocols utilizing calcium imaging techniques● Conceptualizes and validates in vitro models of pain and inflammation based on recent scientific literature● Co-authors scientific manuscripts based on experimental findings

● Transformed a one-person department into a multi-functional contract research organization● Managed inter-departmental team while maintaining effective and clear communication● Executed contract and budget negotiations with Sponsors● Led protocol, ICF and CRF development on behalf of Sponsors● Planned and performed regular internal audits of data and documentation, including TMFs

● Participated in site initiation visits and meticulously completed all relevant documentation, including training documents and 1572s● Worked under Principal Investigator to manage all clinical trials at site● Led all site recruitment and retention efforts● Adhered to Good Clinical Practices (GCP), ICH guidelines, and 21 CFR● Conducted medical device, pharmaceutical, and observational studies

Santa Barbara, Ca, Us

● Worked for a professor in a graduate level Biochemistry laboratory● Contributed to the creation of a field test for gamma hydroxybutyric acid (date rape drug) in alcoholic beverages● Worked with many different laboratory procedures, particularly mass spectrophotometry of the action of related enzymes● Wrote a formal lab report, detailing all procedures and results, as well as areas for future research