The candidate has over 7 years of experience as a research coordinator managing clinical trials and research studies in mood disorders. They lead a team and are responsible for all aspects of clinical trial operations including regulatory documentation, patient recruitment, data collection, budget management, and training staff. The candidate seeks a clinical research associate position to utilize their skills developing and leading research clinics.

1. PERSONAL STATEMENT
I am a highlyeffective and passionate healthcare leader.Ienjoy working with others as well as directing
a team of diverse individuals. I excel in daily operations management and effective communication
effectively with staff, physicians, and administrative leaders. I am loyal, honest, and hardworking. With
over seven years of experience developing and leading research clinics, I would like to transfer these
skills to a clinical research associate position.
WORK EXPERIENCE
UTHealth Center of Excellence on Mood Disorders
Research Coordinator II May 2012- Present
Clinical Trial Development/Maintenance:
 Assisting investigators in submitting IRB applications.
 Working with PI and Sub-Is directly to create protocols and study design in innovative
treatments.
 Submitting the clinical study agreement to contracts.
 Attending investigator meetings.
 Developing a preliminary budget and verifying study costs .
 Helping PI and Director to negotiate the study budget direct costs with sponsor to cover all
costs (F&A costs are not negotiable). Completing coverage analysis.
 Securing necessary study start –up documentation (CDA, FDF, 1572).
 Creating source documents to clinical trials.
 Completing study initiation visits, monitoring visits, and close-out visits.
 Completing any necessary sponsor, CPHS, and FDA audits.
 Overseeing all regulatory documentation.
 Preparing for study closure and archiving all study-related documents.
Patient Recruitment/ Data Collection:
 Obtaining physician signatures on necessary patient documentation.
 Recruiting, prescreening, and scheduling prospective patients.
 Tracking subjects, avoiding lost-to-follow-up, creating new methods of staying in contact.
 Consenting patients for study-related treatment.
 Performing study/protocol procedures in a detailed, accurate manner
 Conducting follow-up interviews and scales with patients
 Collecting blood samples for clinical labs. Processing and shipping lab work.
 Conducting EKGs on patients.
 Maintaining confidential study files.
 Reviewing study files prior to entry into database.
 Documenting and reporting adverse or serious adverse events to FDA, IRB, and DSMB.
Management Responsibilities:
 Leading database management.
 Tracking and maintaining the study budget and payments.
 Overseeing contracts and budgets
 Conducting interviews for new RA positions and working with HR to onboard new employees
 Training new RAs on study protocols and procedures
 Training RAs on fMRI tasks and neuropsychological procedures.
 Overseeing daily procedures in research clinic and outpatient research clinic at HCPC.
 Leading research clinic meetings.
 Leading consortium meetings between Baylor, Texas Children’s, and UTHealth.
 Providing all required training materials (including OSHA, CITI, and required institutional
trainings) and expediting re-certification to research staff.
 Maintaining study-specific supplies
 Reviewing clinic expenses and maintaining clinic budget.
Networking/ Communication:
 Maintaining communication and correspondence (by telephone, email, fax, etc.) with patients,
sponsor, monitor and other site study personnel, including: IRB, UT Office of Sponsored

2. Projects, Memorial Hermann, Baylor College of Medicine, Texas Children’s Hospital, Harris
County Psychiatric Center, UTPhysicians, and Harris Health clinics.
 Marketing the UT Center of Excellence on Mood Disorders via newspaper advertisements,
local radio, Acurian mailings, mass mailings, and speaking engagements.
 Working with local organizations to market research clinic.
 Attending local NAMI and DBSA event to market research programs .
CLINICAL RESEARCH EXPERIENCE:
Research Coordinator May 2012- Present
 A Multicenter, Randomized, Double-blind, Active-Controlled Study of the Efficacy and Safety of
Flexibly-Dosed BMS-820836 in Patients with Treatment Resistant Major Depression. Bristol-
Myers Squibb.
 A Multicenter, Double-Blind, 58 week Rollover Study to assess the Safety and Tolerability of
BMS-820836 in Patients with Treatment Resistant Major Depression. Bristol-Myers Squibb.
 A Double-blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in
Patients With Bipolar Depression. Forest Research Institute, Inc.
 A Double-blind, Placebo-controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy In
Major Depressive Disorder. Forest Research Institute, Inc.
 Searching for Endophenotypes of Bipolar Disorder. NIH.
 A Double Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a
Mood Episode after Stabilization of an Acute manic/mixed Episode in Subjects With Bipolar I
Disorder. Merck/Forest Research Institute, Inc.
 A Double Blind, Placebo Controlled Flexible-Dose Study of Vialzodone in Patients with
Generalized Anxiety Disorder. Forest Research Institute, Inc.
 A Double-Blind Randomized Placebo-Controlled Study of Aspirin and N-Acetyl Cysteine as
Adjunctive Treatments for Bipolar Disorder Patients. Stanley Medical Research Institute.
 Pediatric Bipolar Registry. John S. Dunn Foundation.
 Genomics OfBipolar Disorder.John S. Dunn Foundation. Collaboration with Baylor College of
Medicine.
 Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression. John S. Dunn
Foundation. Collaboration with Mischer Neuroscience.
 A Cluster Randomized, Multi-center, Parallel-group, Rater-blind Study Comparing Treatment
with Aripiprazole Once Monthly and Treatmentas Usual on Effectiveness in First Episode and
Early Phase Illness in Schizophrenia. Otsuka Pharmaceuticals.
 A Phase 3, Multicenter, Four-week, Randomized, Double-blind, Placeb-Controlled, Parallel-
Group Efficacy, and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and
Adolescents with Bipolar I Disorder (Current of Most Recent Episode Manic). Pfizer
Pharmaceuticals.
 A Double-Blind, Placebo-Controlled, Multicenter Study of Sirukumab as Adjunctive Treatment
to a Monoaminergic antidepressant in Adults with Major Depressive Disorder. Janssen
Research and Development.
 An Open-label Long-term Safety Study of Vilazodone in Pediatric Patients With Major
Depressive Disorder. Forest Research Institute, Inc.
 A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of
Levomilnacipran ER in Adolescent Patients with Major Depressive Disorder LVM-MD-11.
Forest Research Institute, Inc.
UNC Chapel Hill School of Medicine
Early Brain Development Studies
Study Coordinator June 2010- May 2012
 Advertised Early Brain DevelopmentStudy Program throughoutthe Chapel Hill Communityand
nationwide using posters,internetforums,mass mailings,and attending both local and national
conferences.
 Persuaded families to enroll in study during brief telephone calls. Coordinated all travel
arrangements such as hotel and flightfor out of state participants.Created visitpackets with all
necessary information to prepare the family for their appointments and travel. Answered
questions to eliminate parents’ concerns.
 Established and maintained a beneficial connection with more than 400 participants and
interacted with them at all regular MRI and developmental appointments.
 Prepared more than 20 newborns,toddlers,or children for MRI scans by rocking them to sleep
or practicing in a mock scanner a month. Encouraged the children to remain still and soothed
worried parents.
 Worked directly with physicians and doctors to provide schedules and assist with physical
assessments. Marketed to medical professionals to encourage clinic referrals. Met with
physicians to brainstorm more advantageous lines of communication for both the study and
their clinics monthly.
 Consulted with clients about additional Growth Hormone treatment and continued monthly
follow-up with participants.Setup training sessions for newlyenrolled families with physicians.

3.  Coordinated buccal and blood sample collection and lab drop off with UNC Bio-Specimen
Processing Lab for more than 400 participants.
 Collected thorough medical summaries and medication lists from prenatal and pediatric
medical records for each child. Obtained medical records from all physicians and clinics.
 Managed Turner database and generated monthly reports for principal investigators.
 Completed travel reimbursements and ordered all necessary supplies for study protocol with
UNC authorized vendors.
American University Human Memory and Cognition Lab
Experimenter/ Private Investigator January 2010-May2010
 Designed and conducted my own study on proactive interference, the inability to remember
new memories because of past memories. Recruited, organized, and conducted 10 patients.
Analyzed and presented my findings to the department.
The Clinical Psychophysiology and Psychopharmacology Lab
CPPL Intern August 2009- January 2010
 At the Uniformed Services University Department of Psychiatry, I entered participant data files.
Conducted approximately three health screenings per week involving measuring EEGs and
EKGs, administering and evaluating Clinical Data Interchange Standards Consortium, Barratt
Impulsiveness Scale,Morning-Eveningness Scale,and Iowa- Gambling Task.Enter participant
data into a database to be used for later analysis on addictive properties of new drugs.
American University Social Psychology Lab
Experimenter/ Lab Assistant September 2008-May 2010
 Organized and conducted lab experiments with a focus on automatic prejudices and snap
judgments in relation to race and sex. Compiled data for later analysis.
Office of Enrollment Services
Office Assistant January 2008- May 2010
 Organized and entered approximately 30 prospective student application files each week.
Assembled new student packets. Organized and planned enrollment events including
Freshman Day, which brings hundreds of prospective students and their families to the
American University Campus.
EDUCATION
Copenhagen University, DIS Copenhagen, DK May 2009
European Culture and HistoryProgram
American University, Washington, DC May 2010
BA, PsychologyMinor: Literature Honors: Overall GPA:3.88/4.0
The University of Texas Health Science Center at Houston School of Public Health May 2017
Masters in Healthcare ManagementProgram
PUBLICATIONS:
 Bauer I, Wu MJ, Meyer T, Mwangi B, Ouyang A, Spiker D, Zunta-Soares GB, Huang H,
Soares JC. The role of white matter in personality traits and affective processing in
bipolar disorder. J Psychiatr Res.2016 Sep; 80:64-72.
 Albert J. Fenoy, Paul Schulz, Sudhakar Selvaraj, Christina Burrows,Danielle Spiker, Bo Cao,
PhD3, Giovanna Zunta-Soares,PrashantGajwani,Joao Quevedo, Jair Soares. Deep Brain
Stimulation of the Medial Forebrain Bundle: Distinctive Responses in Resistant
Depression.. J Affect Disord.2016 Oct; 203:143-51.
 Mwangi B, Hunt SC, Spiker D, Zunta-Soares GB, Soares JC. Predictive classification of
Pediatric Bipolar Disorder using Amygdala Morphometric Features. Presented atthe 2013
Society of Biological PsychiatryAnnual Meeting. (May 2013).
 Mwangi B, Spiker D, Zunta-Soares GB, Soares JC. Prediction of pediatric bipolar disorder
using neuroanatomical signatures of the amygdala. Bipolar Disord.2014 Nov;16(7):713-21.
SKILLS:
 Proficient in Microsoft Word and WordPerfect, Excel, Access, PowerPoint, SPSS, and SAS.
REFERENCES
References are available on request.
Last Updated September 21, 2016