CRA

Posted on: 2009-03-16

Esther Jina Kim LICENSING Licensed pharmacist in the State of Massachusetts February 2009 – Present Permit Number: PH232413 Licensed pharmacist in the State of Indiana July 2006 – Present Permit Number: 26022073A Notary public in the State of California April 1998 – September 2002 EDUCATION AND LICENSING Butler University, College of Pharmacy and Health Sciences August 2002 – May 2006 Indianapolis, IN  Degree: Doctor of Pharmacy (Pharm.D)  Major: Pharmacy University of California, San Diego September 1997 – June 2002 La Jolla, CA  Degree: Bachelor of Science  Major: Microbiology  Minors: Economics; Music Performance Yonsei University September 1999 – December 1999 Seoul, Korea  Study Abroad Program PROFESSIONAL EXPERIENCES Eli Lilly Korea, Seoul, Korea April 2008- December 2008 Senior Clinical Research Associate  Conducted and managed clinical trials in different therapeutic areas such as oncology, psychology, and cardiology in accordance with the applicable ICH, GCP, SOP, FDA and local regulation as a project manager and a site manager. 1. Therapeutic Area: Cardiology A phase 3 study for prasugrel in Asian Acute Coronary Syndrome Subjects who are to Undergo Percutaneous Coronary Intervention  Served as a project manager.  Participated in protocol translation, ICD development, PED translation, and IND submission for KFDA, etc.  Involved in site selections by contacting investigators in 7 sites all over Korea.  Developed Letter of Agreement and budget.  Identified, selected, and managed local vendors required for the study.  Negotiated and communicated with sites for participation.  Coordinated meetings and site visits for investigators and Lilly visitors from the global team  Prepared for start-up meeting. 2. Therapeutic Area: CNS A phase 4 study for atomoxetine in Asian Children Aged 8 to 11 Years with ADHD  Served as a project manager and a site manager.  Monitored 4 sites and closely communicated with site personnel and global study team. (Travel: 20-30%)  Participated in patient enrollment and recruitment.  Trained site personnel for new system such as eCRF and amended protocol.  Utilized electronic database system (eCRF) and worked with site personnel to resolve queries.  Closed out sites and finalized budgets including grants.  Supported team and other colleagues to conduct and to manage clinical trials in accordance with the applicable ICH, GCP, SOP, and Lilly quality system and local regulation.  Served as a topic expert in CT material.  Participated in local SOP development/update.  Trained affiliate members (i.e. CR team members) on updated Global/Local SOP.  Served as a CTMMS administrator and developed SOP and other documents for system.  Served as an Investigator-Initiated Trial (IIT) study coordinator of both oncology studies and overall IIT studies in Korea affiliate.  Involved in communication among investigators, global teams, and affiliate IIT committee members. Eli Lilly Korea, Seoul, Korea December 10, 2007- March 2008 Clinical Research Associate  Conduct and manage clinical trials in accordance with the applicable ICH, GCP, SOP, FDA and local regulation as a project manager and a site manager. 1. Therapeutic Area: Oncology A phase 3 study for pemetrexed (Alimta) in Patients with Locally Advanced or Metastatic NSCLC  Served as a project manager and a site manager.  Performed excellent patient enrollment.  Monitored 4 sites and closely communicated with site personnel and global study team to resolve queries and unclear issues. (Travel: 30%)  Reported SAE and closely communicated with local/global pharmacovigilance teams and sites.  Trained site personnel for new system such as eCRF and amended protocol.  Utilized electronic database system (eCRF) and worked with site personnel to resolve queries. 2. Therapeutic Area: Oncology A Phase 3 for pemetrexed (Alimta) in Extensive-Stage SCLC  Served as a project manager and a site manager.  Monitored 2 sites and closely communicated with site personnel and global study team to resolve queries and unclear issues. (Travel: 20%)  Reported SAE and closely communicated with local/global pharmacovigilance teams and sites.  Participated in interim datalock and close-out.  Trained site personnel for new system such as eCRF and amended protocol.  Utilized electronic database system (eCRF) and worked with site personnel to resolve queries. 3. Therapeutic Area: Oncology A phase 3 for gemcitabine (Gemzar) in Stage III A/B Unresectable NSCLC  Served as a project manager and a site manager.  Monitored 2 sites and closely communicated with site personnel and global study team to resolve queries and unclear issues. (Travel: 10%)  Reported SAE and closely communicated with local/global pharmacovigilance teams and sites.  Trained site personnel for new system such as paper CRF and amended protocol.  Utilized paper CRF and worked with site personnel to resolve queries. CVS Pharmacy, Noblesville, IN July 11 2006 – November 30, 2007 Staff Pharmacist  Serve as a staff pharmacist involved in pharmacy operations, management of business, professional conduct with patients and other healthcare providers including patient consultation, drug utilization review, compounding, dispensing medicines, etc.  As a lead pharmacist, involve in management of other staff members and customer relationships. CVS Pharmacy, Fishers, IN November 2002 – May 2006 Pharmacy Intern/Technician  Involved in entering data and filling prescriptions.  Acquired experiences in patient counseling and other pharmacy issues which strengthened communication skills. Postal Annex, San Diego, California April 1998 – September 2002 Assistant Manager  Utilized in copying, printing, packing, shipping, and many other business supporting services.  Served as a notary public in the State of California. INTERNSHIP EXPERIENCES IN ADVANCED PHARMACY PRACTICE Advanced General Medicine-IU Hospital, Indianapolis, IN April 2006  Acquired experiences in internal medicine service which developed knowledge and skills in a variety of acute and chronic disease states.  Involved in daily roundings with internal medicine team and assessed patients’ disease states and drug-related problems in daily basis. Long-Term Care-Cornerstone Pharmacy, Indianapolis, IN March 2006  Acquired experiences in general geriatric pharmacotherapy and roles of consultant pharmacist by participating in an on-going medication therapy monitoring, assessment, and recommendations in nursing homes.  Involved in the preparation and management of Medicare Part D Plan for residents of nursing homes. Ambulatory Care-VA Medical Center, Indianapolis, IN February 2006  Acquired experiences in the management of ambulatory care patients in the VA health care settings.  Involved in the provision of pharmaceutical care, which included obtaining medication histories, assessing the appropriateness of medication regimens, counseling patients, monitoring therapies, and providing appropriate drug information to both patients and the physicians.  Operated an anticoagulation clinic which directly counseled and monitored anticoagulant medications for the patients. Infectious Disease-Methodist Hospital, Indianapolis, IN November 2005  Acquired experiences in general infectious disease which involved pharmacokinetic calculations, monitoring of patient daily issues of antibiotics, recognition of issues related to microbiology, drug therapy regimen, and other pharmacological issues.  Attended in-service educations for nurses and other health care providers. General Medicine-Community Hospital, Anderson, IN September – October 2005  Participated in chart reviews, monitoring and screening drug interactions, dose recommendations, pharmacokinetics, TPN preparations and calculations, patient counseling (especially in Coumadin and cardiovascular medication), and answering questions regarding various drugs.  Provided several in-service presentations to nurses in the extended care unit.  Involved in the P&T review. Institutional Practice-Witham Hospital, Lebanon, IN August 2005  Worked on both institutional and clinical settings which participated in preparations of IV products, sterile TPN products, oral/topical compounding products, drug recommendations, dispensing, monitoring, medication order screenings, order entry, and answering questions regarding various drugs.  Prepared protocols and several projects for the P&T meeting. Home Health Care- Community Home Care Center, Fishers, IN July 2005  Acquired experiences in the role and function of a home infusion pharmacist in Home Infusion management.  Participated in drug recommendations, dispensing, and monitoring for home infusion therapies, including IV products, nebulizing medications, chemotherapy, and TPN.  Directly involved in communication with patients, physicians, and other health professionals.  Visited patients with visiting nurses at patients’ house to experience the real world of Home Infusion. Clinical Community Practice-Walgreens, Carmel, IN Department: Patient Care Center June 2005  Operated the patient care center in community pharmacy which performed screenings of cholesterol, diabetes, and osteoporosis and patient education.  Attended local health events and a Black Expo. Pharmaceutical Industry – Eli Lilly and Company, Indianapolis, IN Department: Global Operations Labeling Department (GOLD) May 2005  Acquired experiences in the pharmaceutical industry by learning pharmacists’ roles within an industrial setting (i.e. Clinical Research Administrators, Medical Information Associates, Disease State Specialists, etc.)  Participated in regulatory affairs, drug development process, and labeling medical products. PHARMD RESEARCH AND PRESENTATIONS Butler University April 2006 Undergraduate Research Conference “Utilization of Inhaled Corticosteroids in the Management of COPD in a VA Population” PERSONAL INTERESTS  Served as an accompanist in a church band called “5B2R” at Indianapolis.  Served as an accompanist for Sunday and Wednesday services in church at Indianapolis.  Board member of Good Work Korea (nonprofit organization for Korean-War Veterans) LANGUAGE Fluent in English and Korean REFERENCES Available upon request