Soo Hyun Kim, PhD, CCRC (ACRP certified)

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New York, NY 10001

Phone: 917-***-****

Email: ac8fvg@r.postjobfree.com

Immigration status: US Permanent Resident (Green card holder)

Professional Summary: ACRP certified clinical research scientist with more than 10 years experience in laboratory and preclinical/clinical research field including two years of monitoring oncology trials for a pharmaceutical company in US/South Korea. Adept with preclinical work on CNS targets and phase I/II study design for oncology trials. Responsible for grant management and mentoring junior scientist in academia, biotech and pharmaceutical company.

Summary of Skills:

Good computer skills: Microsoft office, statistical analysis software (GraphPad Prism and R) and CRScube (CTMS and EDC)

Knowledge of ICH/GCP guidelines (ACRP-CCRC certified)

Strong attention to detail

Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

Excellent oral and written communication skills

Understanding of drug development

Professional Experience:

Sr. Research Scientist, Pharmacological Science July 2018 to Present

Icahn School of Medicine at Mount Sinai, New York, NY

Responsible for in vitro pharmacology assay development, validation and qualification that support the preclinical activities of two lead compounds in Alzheimer’s disease drug development

Plan, execute and troubleshoot experiments to evaluate drug candidates’ specificity and selectivity

Write and edit grant progress reports of preclinical research and ensuring compliance with regulatory requirement of preclinical research lab

Manage grant budgets: submission of proposal, progress reports, distribute funds, complete reconciliation of total $ 3,754,170/yr

Responsible for data entry/QC of GCP oncology clinical trial data points into the appropriate database and source data verification

Clinical Research Scientist, Neuroscience September 2015 to November 2017

NYS Psychiatric Institute/Columbia University, New York, NY

Led a project focused on discovering biomarkers in depression patients treated with anti-depressant

Conducted statistical analysis using GraphPad Prism software

Wrote manuscripts, protocols, SOP and final reports

Managed projects budgets and grants: submission of proposal, progress reports, distribute funds, complete reconciliation of total $ 1,515,140/yr

Mentor and train junior scientists

In-house Clinical Research Associate (CRA)/Clinical Scientist, Oncology May 2013 to March 2015

OncoVenture/National Cancer Center, Goyang-si, South Korea

Assisted with phase I and II multi-center clinical trial study design and protocol development for anti-cancer drug development, managed the progress of clinical studies and ensured compliance with all regulatory requirements

Developed and reviewed clinical study design, clinical trial protocols, study procedure planning and investigator brochure

Participated in site selection and study start-up and monitoring plan development

Ensured accurate, current and complete case report forms (CRFs), source data verification, source documents and essential documents

Completed remote/risk-based monitoring, audits and site visits

Worked with contract research organization (CRO) contracts and budgets

Ensuring the compliance with ICH/GCP guidelines, SOPs and all regulatory requirements

Ensured accountability of investigational product

Attended site visits and investigator meetings to review trial progress, recruitment plan and regular enrollment updates

Assisted with resolution of investigational site/data queries

Reviewed all serious adverse events (SAEs), protocol deviations and violations

Responded to requests from investigative sites in a timely fashion

Provided general support to the lead CRA

Involved in a biomarker studies to develop a companion in vitro diagnostic (IVD) test for patient stratification

Involved in 2 phase I oncology trials in solid tumors and 2 phase II oncology trials in lung cancer and gastric cancer in US and South Korea

Research Fellow, Pharmacogenetics September 2011 to April 2013

Stanford University, Palo Alto, CA

Led a project identifying all the major drug-metabolizing cytochrome P450 (CYP) enzymes and the genetic variants: 2 NIH grants

Authored and reviewed project reports and manuscripts

Staff Scientist November 2010 to June 2011

Coriell Research Institute, Camden, NJ

Responsible for developing in vitro drug screening platform for CNS diseases using induced pluripotent stem cell lines: 2 NIH grants

Managed vendor contracts, study progress and budgets

Trained junior scientists

Research Fellow, Oncology May 2007 to November 2010

Children’s Hospital Boston/Harvard Medical School, Boston, MA

Led a therapeutic antibody development project to block tumor angiogenesis in melanoma: 2 NIH grants and 1 Harvard Stem Cell grant

Authored manuscripts and grant progress reports

Education:

Ph.D., Biochemistry, the Ohio State University, 2006

M.S., Molecular Biology, Seoul National University, 2000

B.S., Biology, Catholic University, 1996

Certification:

Association of Clinical Research Professional (ACRP)-CCRC, 2018

Languages:

English

Korean

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