Sophia Q. Chang

*** ****** *** ***** *****, TX 972-***-****

g8kxad@r.postjobfree.com

Objective: Obtain work experience in the clinical research field.

Education:

University of Texas at Dallas, Richardson, Texas

Bachelor of Arts, Biology 2010

GPA: 3.496

Work Experience:

University Hills Clinical Research, Irving, TX Nov. 2010 - Present

Clinical Research Coordinator

- Organize, coordinate, and oversee integrity of human research projects

- Recruit patients, conduct patient pre-screening to determine eligibility, and obtain

patient medical history

- Consent patients and schedule patient visits

- Obtain study related information from patients during visits

- Take vital signs, perform and transmit ECG, and perform urine drug screen on

patients

- Process, package, and ship laboratory samples

- Create, revise, and manage regulatory documents

- File and maintain patient source documents, regulatory binders, and reference binders

- Account for investigational products and temperature of their storage

- Dispense investigational drugs

- Prepare for and attend SIV, IMV, and COV

- Maintain correspondence with monitors, IRB, and sponsors

- Attend investigator meetings and study specific tele-conferences

- Perform CRF data entry

Protocols:

F. Hoffman-La Roche LTD

WN25305 (Phase III) Feb. 2011 - Present

A Phase III, multi-center, randomized, 12-week, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia treated with antipsychotics followed by a 40-week double-blind, parallel-group, placebo-controlled treatment period.

- Attended Pride Investigator Meeting (Jul. 2011)

WN25308 (Phase III) Feb. 2011 - Present

A Phase III, multi-center, randomized, 24 week, double-blind, parallel-group, placebo-controlled study to evaluate efficacy and safety of RO4917838 in stable patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics followed by a 28 week, double-blind treatment period.

- Attended Pride Investigator Meeting (Jul. 2011)

WN25333 (Phase II/III) Mar. 2011 - Present

A phase II/III, multi-center, randomized, 4-week, double-blind, parallel groups, placebo and active-controlled trial of the safety and efficacy of R)4917838 vs. placebo in patients with an acute exacerbation of schizophrenia

Ortho-McNeil Janssen Scientific Affairs, LLC*

R092670-SCA-3004 (Phase III) Nov. 2010 - Present

A Randomized, Double-Blind, Placebo-Controllled, Parallel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder

R092670-SCH-3006 (Phase IV) Nov. 2010 - Present

A Fifteen-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared with Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults with Schizophrenia Who Have Been Recently Released From Jail

- Attended Pride Investigator Meeting (Jan. 2011)

Takeda Global Research & Development Center Inc.

Lu AA21004_316 (Phase III) Nov. 2010 - Present

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (10 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder

- Attended Prism Investigator Meeting (Feb. 2011)

Lu AA21004_314 (Phase III) Jan. 2011 - Present

A Phase 3, Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 (15 and 20 mg) in Subjects With Major Depressive Disorder

Novartis

CILO522DUS01 (Phase IV) Dec. 2010 - Present

A 12-week, Randomized, Multi-center, Open-Label, Iloperidone, (12-24mg/day), Flexible Dose Study Assessing Efficacy, Safety and Tolerability of Two Switch Approaches in Schizophrenia Patients Currently Receiving Risperidone, Olanzapine or Aripiprazole (i-FANS)

ILO522D2301 (Phase III) Feb. 2011 - Present

A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate prevention of relapse in patients with schizophrenia receiving either flexible dose iloperidone (Fanapt) or placebo in long-term use (up to 26 weeks) followed by up to 52 weeks of open-label extension

Shire

SPD489-204 (Phase II) Feb. 2011 – May. 2011

A Phase 2, Multicenter Study with Open-label and Randomized Double-blind Placebo-controlled Withdrawal Phases to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults with Schizophrenia and Predominant negative Symptoms who are Clinically Stable and Taking Stable Doses of Atypical Antipsychotic Medication

SPD489-205 (Phase II) Dec. 2010 - Present

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults with Clinically Significant, Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

AstraZeneca

D4130C00004 (Fixed) (Phase III) Dec. 2010 - Present

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

D4130C00007 (Long-Term Safety) (Phase III) Dec. 2010 - Present

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-Controlled, Phase III, Long-Term Safety and Tolerability Study of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate response to Antidepressant Therapy

Danone Research- Centre for Specialised Nutrition

S-Connect Alz.1.C/C (Phase III) Dec. 2010 – Aug. 2011

A Randomized Controlled Trial to Assess the Efficacy of a Food in Patients with Mild to Moderate Alzheimer's Disease using Alzheimer's Disease Medication

Cephalon- Insights Into Medicine

C10953/3072 (Phase III) Dec. 2010 - Present

A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 to 200 mg/day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

C10953/3074 (Phase III) Dec. 2010 - Present

A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated with Bipolar I Disorder

Forest Research Institute, Inc.

RGH-MD-05 (Phase III) 2011

A Double-blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia

RGH-MD-11 (Phase III) 2011

Evaluation of the Long-Term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia

RGH-MD-33 (Phase III) 2011

A Double-blind, placebo-controlled evaluation of the safety and efficacy of cariprazine in patients with acute mania associated with bipolar I disorder

University of Texas at Dallas, Richardson, TX

Chemistry Research Assistant 2009 - 2010

- Synthesize N-methylated reversible cyclic peptides, designed to protect nanotubes to prevent them from aggregating in solution

Chemistry Intern 2005

- Assist chemistry graduate students with laboratory experiments

Certifications:

ICH-GCP Certified 2010

IATA Certified 2011

Language Skills: English Chinese Japanese Basic Spanish

Computer Skills:

Type 102 wpm Microsoft Office Adobe Photoshop Desktop Publishing

Medidata Inform Bioclinica Oracle Clinphone Phaseforward iXRS

My Study Portal CardioPortal Web Oasis UBC

Volunteer Experience:

Presbyterian Hospital of Plano, Plano, TX 2003 - 2010

Volunteer

- Weekly volunteering at the ER, take patient vital signs, answer calls, discharge patients

Activities & Honors:

Outstanding Teaching Award 2010

- $500 award from the Department of Biology based on nominations from students

Terry Scholar August 2006 – May 2010

- Based on high school GPA, SAT score, academic record, community service, and leadership

- Social Chair 2006 – 2007; Secretary 2007 – 2008; Terry Mentor 2009 – 2010

Gamma Sigma Sigma 2009 – 2010

- National service sorority

Undergraduate Research Scholarship Competition 2009

- $500 competitive research grant based on proposal

Key Club International Scholarship 2006

- $1000 award based on high school academic, leadership, and community service achievements

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