Ruonan Zhao, Phd Email & Phone Number

Boston, Ma, Us

United States

• Prepare, review, and edit regulatory documents including CSRs, protocols, IBs, narratives, and ICFs.• Interpret and summarize scientific data from clinical trials and other sources to support regulatory submissions and communications.• Participate in cross-functional team meetings to establish timelines, discuss document key messages, coordinate and facilitate team discussions.• Collaborate and effectively communicate with client subject matter experts and internal teams to ensure accurate and timely completion of documents. • Coordinate the review process for regulatory documents, ensuring adherence to internal procedures and regulatory requirements.• Manage multiple projects and deadlines simultaneously with excellent attention to detail and organizational skills.• Perform quality control checks on a variety of regulatory documents to ensure consistency and accuracy. • Maintain knowledge of applicable company guidelines and SOPs and international (ICH) and government guidelines and regulations.• Familiarity with data/document management systems (eg, Veeva Vault) and document reviewing tools.

• Reviewed regulatory clinical documentations including clinical study protocols to comprehend the study design and eligibility criteria of 10+ phase I clinical trials.• Collaborated with cross-functional teams, including the medical team, enrollment coordinators, and clinical study managers, in support of clinical trial recruitment.• Implemented communication skills to explain complex clinical/scientific concepts, such as clinical study design, to potential study participants during phone screening.• Performed data queries and entries using the electronic recruitment database.

• Led and managed 3+ research projects leading to 1 review paper and 3 peer-reviewed publications• Independently analyzed and interpreted 2 single-cell RNA sequencing datasets for trends• Led and collaborated with multidisciplinary teams facilitating communication and cooperation among scientists and research technicians at varying levels from 5 core facilities• Led project discussions and research presentations on monthly and quarterly basis• Created, edited and reviewed scientific documents including 2 grant proposals, 10+ abstracts, 4 publications, 10+ presentation slide decks, 2 study proposals and numerous research protocols/Standard Operating Procedures (SOPs)• Routinely communicated research findings to a wide variety of audiences orally and in writing• Experience with Microsoft Word, Excel, Outlook, PowerPoint, Adobe Acrobat, Adobe Illustrator and Adobe Photoshop• Conducted thorough scientific literature searches and reviews of peer reviewed data to understand complex scientific and medical concepts• Maintained laboratory records and operations following Good Laboratory Practices (GLP)• Mentored 10+ trainees on research design, laboratory protocols and data analysis

• Reviewed and queried trial participant medical record data from patient charts using electronic data management systems.• Organized data into electronic case report forms (eCRFs) for 20-30 clinical trial participants every month.• Familiarity with oncology clinical trial design and terminologies.• Maintained spreadsheets that track the status of data collection.

Kansas City

• Managed 3 independent research projects involving 3 model systems including 7 clinically-derived cell lines• Utilized both in vitro cell-based assays and mouse xenografts to examine the effect of trial drug and gene candidates on early breast cancer progression• Identified candidate gene biomarkers for early breast cancer disease progression in human tissue samples by assessing trends and correlations between gene expression and breast cancer development• Processed human breast cancer tumor samples to isolate blood cells, tumor cells and stromal cells for subsequent immunization and drug treatment studies• Developed, modified and standardized research protocols involving multiple techniques including cell culture, qPCR, rtPCR, western blot, multi-dimensional flow cytometry, zymography, immunostaining, H&E, immunoprecipitation, ELISA, nucleic acid extraction/purification, transfection and more

Doctor Of Philosophy (Phd), Anatomy And Cell Biology

Bachelor Of Arts, Biology, Gpa:3.951

Activities and Societies: Member of Phi Epsilon Honor Society; President of the International Student Association (2014-2015); Member.