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CCRC-ACRP certified

New York, New York, United States
October 30, 2018

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Soo Hyun Kim, PhD, CCRC (ACRP certified)

*** *** ***

New York, NY 10001

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


Immigration status: US permanent resident (Green card holder)

ACRP certified clinical and research professional with laboratory, preclinical and phase I/II oncology clinical trial experience. Working in various settings such as academics, biotechnology companies and pharmaceutical companies. Seeking clinical research opportunity.

Professional Experience:

Sr. Research Scientist July 2018 to Present

Pharmacological Science

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 for 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

Clinical Research Scientist 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

Mentor and train junior scientists

Clinical Research Scientist, Oncology May 2013 to March 2015

OncoVenture/National Cancer Center

Goyang-si, South Korea

Assisted clinical study director and involved in 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 all regulatory requirements

Specific duties include:

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

Wrote and edited Investigator brochure

Participated site selection and study start-up and monitoring plan developmen

Reported and documented safety issues

Ensured accurate case report forms (CRFs), veritable data, source documents and essential documents

Participated monitoring, audits and site visits

Worked with contract research organization (CRO) contracts and budgets

Ensuring the compliance with Good Clinical Practices (GCPs) and all regulatory requirements

Ensured accountability of investigational product

Attended site visits and investigator meetings to review trial progress

Reviewed all serious adverse events, protocol deviations and violations

Responded to requests from investigative sites in a timely fashion

Assigned global clinical trials:

NOV120101 Phase 2 study in NSCLC patients with acquired resistance to 1st generation EGFR tyrosine kinase inhibitor (NSCLC)/ Identifier: NCT01718847

NOV120401 (CKD-516) for advanced solid tumors, phase I/ Identifier: NCT02300467

A phase I-II study of HM781-36B combined with paclitaxel and trastuzumab in HER-2 positive advanced gastric cancer/ Identifier: NCT01746771

First in human dose escalation study of Vactosertib (TEW-7191) in subjects with advanced stage solid tumors/ Identifier: NCT02160106

Research Fellow 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

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

Managed vendor contracts, study progress and budgets

Trained junior scientists

Research Fellow May 2007 to November 2010

Cancer Biology

Children’s Hospital Boston/Harvard Medical School

Boston, MA

Led a therapeutic antibody development project to block tumor angiogenesis in melanoma

Authored manuscripts and grant progress reports


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

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

B.S., Biology, Catholic University, 1996


ACRP-CRC, 2018

ACRP Trainings:

GCP for the experienced CRA: improving monitoring efficiency and effectiveness, 2018

ICH gap analysis tool, 2018

Risk-based monitoring: the essentials for CRAs, 2018

GCP for the experienced CRC: partnering with your investigator to reduce risk and avoid common inspection findings, 2018

The drug development process: improving trial feasibility and exploring your growth potential, 2018

Theory to practice: operationalize your clinical study protocol, 2018

Key skills for ensuring quality control through risk-based decisions, 2018

Building quality management systems, 2018

From FDA 1572: get it right the first time, 2018

Inspection readiness: best practices for managing inspections, 2018

Trial Feasibility and selection: their impact on accrual, 2018

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