Shuo You Email & Phone Number

Great Neck, Ny, Us

Great Neck, Ny, Us

Chicago, Illinois, Us

Responsible for developing the Clinical Research Program at the Anesthesia department of Northwell Health.

Blue Bell, Pa, Us

- Served as the main Clinical Trial Specialist (CTS) for two Clinical Registries, actively managed> 30 clinical sites.- Coordinated 10+ site Closeout Visits (COVs) with the sites. Worked closely with data management, payment specialist, and the CRA to resolve all pending items for site closure. Updated CTMS info and cleaned up the eTMF to ensure regulatory compliance. - Gained extensive experience in eTMF management and maintenance, Uploaded 500+ regulatory documents to the Trial Master File as part of a quality control internal audit.- Preformed remote clinical data monitoring and resolution, site progress status tracking, in-house site management, documentation filing, payment reconciliation.- Being identified as 'Rehirable' by UBC.

Bronx, New York, Us

Promoted again within the institution to Project Director of Montefiore Sickle Cell Center for Adults. - Continue to lead all the adult Sickle Cell Clinical Trials at Montefiore/Albert Einstein.- Served as the Regulatory Liaison for all the studies. (Regulatory Coordinator)- Expanded our site's impact by taking on more investigator-initiated trials. (including K23, NIH grants and industry collaborative grants: we write the protocol while the Pharma company provides the funding support)- Published 7 co-author manuscripts on Sickle Cell leg ulcers by using our Clinical Trial data: https://www.researchgate.net/scientific-contributions/Shuo-You-2165146934

Bronx, New York, Us

Oversee and orchestrate 10+ clinical trials at Montefiore Sickle Cell Center for Adults.- Directly manage two Study Coordinators and one Research Nurse, leading the research team.- Organize overall research activity, implement enrollment strategies, monitor protocol compliance.- Provide on-going support to the FDA sponsored investigator-Initiated IND trial (2 Million $ study): Identify and open new study sub-sites, conduct site monitoring visits, optimize protocol workflow.- Support new project development; extend collaborations with basic science and Pediatric departments by developing and implementing new investigator-initiated collaborative research projects.

Bronx, New York, Us

Coordinated 8 Sickle cell clinical trials with full compliance to IRB, GCP and FDA guidelines. Set up and led an FDA sponsored $2 million dollar multi-center IND trial. Expanded the clinical research team from only 1 Study Coordinator to 3 Study Coordinators and a dedicated Research Nurse.- Generated >$260k additional income through well-organized clinical research, following promotion.- Received recognition letter from a multi-center trial (NCT02633397) Lead PI for quality of work. - Developed 20+ eCRFs, lab manuals, SOPs, SIV/training material, study flyer; Conducted SIV, provided on-going sub-site support, Prepared FDA progress reports, DSMB meetings, protocol/budget amendments.- Trained new study coordinators; supported medical residents’/Fellows’ research projects.

Atlanta, Ga, Us

Worked closely with pathologists, oncologists and IT experts as a team to build an integrated Clinical Breast Cancer Database (linked to Pathology samples). Professionally extracted 600+ patient’s clinical data into the database and summarized the new discoveries for publication.- Published two clinical research manuscripts on Oncotype DX testing (PMID: 30230095, PMID: 29305309).- Developed strong coordinating skills; capable of coordinating activities across functional departments.

Atlanta, Ga, Us

Worked in the NCI-designated Cancer Center for 5 years. Research focused on tackling current clinical challenges: revealing Lung Cancer radiation resistant mechanisms (PMID: 24362463) and finding effective new target therapy for Ocular Melanoma (PMID: 30563937). - Obtained 3 Research Grants, including a national Grant in China.- Published 20+ widely cited articles, including a co-author manuscript in journal: Cancer Cell. (journal's impact factor: 38.585 in the year 2021)- Actively helped co-workers with their research projects, following 10+ co-author papers accepted.- Developed several experimental assay protocols which became the gold standard of several labs.- Complete bibliography: https://www.ncbi.nlm.nih.gov/sites/myncbi/1n3p7xr3ku7QP/bibliography/49718913/public/?sort=date&direction=descending

Doctor Of Medicine - Md, Medicine

Doctor Of Philosophy - Phd, Endocrinology

Data Analyst Nanodegree

Programming For Data Science Nanodegree