CV-Spiker_Danielle Oct 2015
- 1. DANIELLE SPIKER 3014 ½ Arbor Street Houston, TX 77004 Phone: 704-608-6496 Email: spiker.danielle@gmail.com EDUCATION: • Copenhagen University, DIS Copenhagen, DK May 2009 European Culture and History Program • American University, Washington, DC May 2010 BA, Psychology Minor: Literature Honors: Overall GPA:3.88/4.0 • University of North Carolina Chapel Hill, NC May 2012 Foundation chemistry courses and required labs GPA: 3.33/4.0 • The University of Texas Health Science Center at Houston May 2017 Estimated graduation School of Public Health, Masters in Healthcare Management Program RELEVANT COURSES AND PROJECTS: Honors Capstone Independent Study August 2009-May 2010 o Completed a literature review and proposed a study on the inability or deficiency in interpreting social cues and conducting social interactions within populations of children with Autism Spectrum Disorder. Used a clinical database to investigate the relationship of executive functioning in a preschool sample of children with autism and autistic symptomatology as well as adaptive behavior. Measures included the Autism Diagnostic Observation Scale, PDD Behavior Inventory, Vineland Adaptive Behavior scale, Leiter-R (IQ), and the Behavior Rating Inventory of Executive Function. Research Methods in Social/ Clinical Psychology August 2009- December 2009 o Conducted an original study on the effects of co-rumination among mothers and daughters. Compared the relationship of co-rumination between mother’s and daughters with peer same-sex relationships. Then analyzed both relationships correlation to female’s self-esteem. Found that females with positive relationships and less co- rumination find self-esteem within their mother-daughter relationship while females with lower self-esteem co- ruminated more with peers. EXPERIENCE: UT Health Sciences School- Houston Mood Disorder Clinic Research Coordinator II May 2012- Present • Submitting regulatory documents to IRB, Sponsor, DSMB, and FDA • Submitting the clinical study agreement to contracts • Attending investigator meeting(s) • 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) • Preparing for study initiation • Obtaining physician signatures • Recruiting subjects • Prescreening subjects over the phone and at Harris County Psychiatric Center • Screening and scheduling subjects
- 2. • Getting voluntary subject consent • Performing study/protocol procedures in a detailed, accurate manner • Conducting follow-up interviews and scales with patients • Maintaining study files • Reviewing study files prior to entry into database. • Leading Database management • Tracking and maintaining the study budget and payments • Tracking subjects, avoiding lost-to-follow-up, creating new methods of keeping in touch with subjects • Documenting an adverse event, including: describing the event, severity and frequency, treatment, resolution • Reporting adverse events to FDA, IRB, and DSMB. • Collecting blood samples for clinical labs. • Conducting EKGs on patients • Processing and shipping lab work • Maintaining communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel, including: IRB, UT Office of Sponsored Projects, Memorial Hermann, and Harris Health clinics. • Creating source documents to clinical trials. • Helping study monitors with corrections to source documents. • Maintaining study-specific supplies • Preparing for study closure and archiving • Marketing the UT Center of Excellence on Mood Disorders via newspaper advertisements, local radio, Acurian mailings, • Working with local organizations to market research clinic • Attending local NAMI and DBSA event to market research programs • Conducting interviews for new RA positions and working with HR to onboard new employees • Training new RAs on study protocols and procedures • Overseeing daily procedures in research clinic. • Assisting new investigators in submitting IRB applications and recruiting subjects. • Working with PI and Sub-Is directly to create protocols and study design in innovative new treatments. 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 Of Bipolar Disorder. John S. Dunn Foundation. Collaboration with Baylor College of Medicine.
- 3. • 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 Treatment as 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. UNC Chapel Hill School of Medicine Department of Psychiatry Early Brain Development Studies Study Coordinator June 2010- May 2012 o Advertised Early Brain Development Study Program throughout the Chapel Hill Community and nationwide using posters, internet forums, mass mailings, and attending both local and national conferences. o Persuaded families to enroll in study during brief telephone calls. Coordinated all travel arrangements such as hotel and flight for out of state participants. Created visit packets with all necessary information to prepare the family for their appointments and travel. Answered questions to eliminate parents’ concerns. o Established and maintained a beneficial connection with more than 400 participants and interacted with them at all regular MRI and developmental appointments. o 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. o 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. o Consulted with clients about additional Growth Hormone treatment and continued monthly follow-up with participants. Set up training sessions for newly enrolled families with physicians. o Coordinated buccal and blood sample collection and lab drop off with UNC Bio-Specimen Processing Lab for more than 400 participants. o Collected thorough medical summaries and medication lists from prenatal and pediatric medical records for each child. Obtained medical records from all physicians and clinics. o Managed Turner database and generated monthly reports for principal investigators. o 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-May 2010 o Designed and conducted my own study on proactive interference, the inability to remember new memories because of past memories. Recruited, organized, and ran 10 participants across 2 separate experiments. Analyzed data and presented my findings to my memory and cognition class. The Clinical Psychophysiology and Psychopharmacology Lab Bethesda, MD CPPL Intern August 2009- January 2010 o 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-
- 4. 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 o 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 o 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. SKILLS: • Computer: o Proficient in Microsoft Word and WordPerfect, Excel, Access, PowerPoint, SPSS, SAS, Superlab, and Medialab. Leadership/ Achievement: • American University, Washington, DC May 2010 o Dean’s Scholarship, Dean's List, Barnard Scholar, University Honors in Psychology, Phi Beta Kappa Member, Magna Cum Laude • Freshman Service Experience Student Leader August 2008 o Led a student volunteer group at nearby DC public school to build and organize the elementary school’s first library. Painted murals in student halls. • Best Buddies AU Chapter Historian Sept 2008- May 2010 o Created long lasting student relationships with teens and adults with severe disabilities. Planned and created bi-weekly events and outings for buddies and mentors. As a historian, I obtained consent from members and cataloging these experiences in photographs and scrapbooks. • Student Peace Alliance Secretary and Co-Founder Jan 2008- May 2010 o Established and planned the student-led organization of thirty members, which supports the establishment of the Department of Peace. Motivated other students to fight against all forms of violence. Organized events such as the showing of Hometown Baghdad and planned events for fall of 2008 including a peace concert on campus. Last Updated 7/6/2015