Clinical Research Coordinator II
Resume:
Diana Kim
Philadelphia, PA *9104
**********@*****.***
EXPERIENCE
Thomas Jefferson University., Philadelphia, PA Clinical Research Coordinator II
APRIL 2017 - PRESENT
With minimal supervision, coordinate Phase I-IV clinical trials. Recruit, consent and screen patients according to protocol. Schedule patient visits and any necessary testing. Monitor patients per protocol requirements and ensure adherence to protocol requirements. Organize and maintain all documentation required by the sponsor - including source documentation, case report forms, and research charts. Collect, review and report study data, complete case report forms and resolve data queries. Maintain and keep track of inventory for multiple studies. Process and ship study specimens including blood, urine and tissue samples in accordance with IATA guidelines.
Participate in initiation, monitoring, audit and close-out visits. Assist in the development/maintenance of study specific case report forms and source document tools, show vigilance in patient safety, protocol compliance and data quality. Adhere to all Thomas Jefferson University, FDA and GCP guidelines. Planned Parenthood of Southeastern Pennsylvania., Upper Darby, PA Reproductive Health Center Assistant
JAN 2016 - AUGUST 2017
Conduct patient interviews and complete all necessary forms and records on patients in an accurate manner.
Obtain blood and urine specimens including performing venipuncture from patients and follow the center procedures for the completion and follow-up of lab work, including process for providing lab results to patients.
Provides education and counseling in a non-judgmental manner to patients by providing support and information on reproductive and sexual health issues. Perform receptionist duties for the Center by following the established appointment schedule system, greeting patients, and maintaining the patient log. Participate in maintaining uniform patient record systems, e.g. computer data, patient filing system. ONGOING RESEARCH PROJECTS
“Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids.” Sponsor: AbbVie.
“A Phase 3b Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Combination with Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women.” Sponsor: AbbVie
“Exosomes as an early line of defense against HIV-1 infection.” Sponsor: National Institute of Allergy and Infectious Diseases
“A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone.” Sponsor: Estetra SPRL.
SKILLS
Proficient with
Microsoft Office,
EPIC, NextGen, EHR.
Knowledge of
Medical
Terminology,
ICD-10, and CPT
coding.
Experience in a lab
and clinical setting.
Familiar with
ICH-GCP guidelines.
LANGUAGES
Fluent in English and
Korean
Conversational
Spanish
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“TREETOP: A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor.” Sponsor: Sera Prognostics.
“Inter-examiner Agreement of a Novel Device for the Measurement of Cervical Dilation in Labor: A Randomized Controlled Trial” Sponsor: Elm Tree Medical Inc.
“Behavioral Principles in Contraceptive Decision-Making” Sponsor: Unfunded. COMPLETED RESEARCH PROJECTS
“A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination with Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women.” Sponsor: AbbVie.
“Placebo-controlled trial of Bupropion for Smoking Cessation in Pregnant Women” Sponsor: National Cancer Institute.
EDUCATION
University of Georgia, Athens, GA B.S. in Biology AUGUST 2005 - DECEMBER 2009
Minor in Spanish
CERTIFICATIONS
CITI Biomedical Research, CITI Good Clinical Practice, CITI Clinical Research Coordinator, CPR
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