CHARLTON_MATITA_RESEARCH CV_JUNE 2016

MATITA CHARLTON27 Viking Oak, San Antonio, TX 78247

Cell: (972) 900-9692; [email protected]

HONORS, CERTIFICATIONS AND EDUCATION

CCRC (Certified Clinical Research Coordinator), ACRP, September 2010 (renewed every two years) Received complimentary attendance to the 2015 ACRP Global Conference (based on essay entry) University of Texas at San Antonio, Bachelors in Psychology

o Graduated Magna cum Laude, G.P.A. in major: 4.00o National Dean’s List, Psi Chi National Honors Societyo Numerous scholarships including Valedictorian scholarships

MEDICAL RESEARCH TRAINING

Collaborative IRB Training Initiative (CITI) course in The Protection of Human Research Subjects Trained in Electronic Case Report Form systems: Phase Forward InForm, Oracle Clinical Remote Data

Capture (OC-RDC Onsite), Trial Access Online (TAO), Electronic Data Capture, Medidata Rave Various job-specific and entrepreneurial software: Fatigue Avoidance Scheduling Tool, BrainMap, ACE

marketing database, Schizophrenia Trials Network Data Management system, Centricity healthcare UT Health Science Center research courses: OVID, PubMed, CINAHL, EndNote, Conducting Clinical

Trials, Phlebotomy and Lab Draws Trained in GCP compliance and specific protocols through: Pfizer, Merck, Eli Lilly and Company, Bristol-

Myers Squibb, Anadys Pharmaceuticals, Sanofi-Aventis, Catalyst Pharmaceutical Partners, Health Decisions

ADDITIONAL SKILLS

Audit preparation activities Grant research, editing, and submission Ensuring training compliance Editing, proofreading Conference preparation and registration Advertising pharmaceutical trials

EXPERIENCE IN THE FOLLOWING THERAPEUTIC AREAS

Asthma Allergy Hepatitis C

clinical trials Substance

abuse Alcohol

abuse Schizophren

ia

Weight loss and diet Arthritis ADHD and

dyslexia Cognitive

performance & sleep deprivation

PROFESSIONAL EXPERIENCE

North East Independent School District, Nimitz Middle School, San Antonio, TexasSpecial Education Instructional Assistant, 2013 – Present

mailto:[email protected]

Matita Charlton, of 5 (972) 900-9692, [email protected]

Teach and take care of students, grades 6-8, who struggle with a variety of developmental issues, including: cerebral palsy, seizure disorder, ADHD, dyslexia, dysgraphia, Down syndrome, autism, mental retardation.

Assist teachers in preparing lesson materials and in classroom management. Modify lesson materials for special education students.

Discovery Clinical Trials, San Antonio TexasCertified Clinical Research Coordinator, 2012 – 2013

Recognized with bonus for exceptionally meeting enrollment numbers. Recruited, pre-screened, screened, and randomized patients who met complex protocol criteria. Advertised studies to patients at health fairs and in the clinic. Scheduled periodic monitoring visits and prepared charts for source document verification. Was responsible for leading a team to prepare for a major CRO audit. Performed study visits and assessments (vitals, EKGs, labs, spirometry, allergy testing). Prepared and maintained confidential source documents and research charts for all patients. Submitted official reports to Institutional Review Boards. Resolved queries and entered data into various web-based Electronic Data Capture systems. Maintained regulatory files for research studies.

Teacher Enrichment Initiatives, UT Health Science Center, San Antonio, TexasResearch Area Specialist, 2011 – 2012

Data management: entered data, cleaned, downloaded, and prepared data for analysis. Assisted in hosting professional development conferences and workshops and evaluations of workshops. Literature management: organized, catalogued, and categorized literature for manuscripts. Obtained elusive materials – many of which were out of print. Filed and indexed educational research and journal articles in Excel databases. Prepared bibliographies and verified citations. Assisted in manuscript preparation and other grant-related projects.

Alamo Medical Research, San Antonio, TexasCertified Clinical Research Coordinator, 2009 – 2011

Became certified through ACRP as a Certified Clinical Research Coordinator after demonstrating understanding and application of FDA and regulatory compliance.

Acted as a liaison between investigators, IRBs, primary care providers, and sponsors. Recruited, pre-screened, enrolled, screened, and randomized patients who met Inclusion/Exclusion criteria. Performed medical chart reviews and screened potentially eligible participants. Consented patients, provided patient education, and counselled patients on drug accountability. Ensured staff training requirements were completed and documented. Scheduled periodic monitor visits and prepared charts for source document verification. Maintained regulatory documents and submitted IRB study initiation and progress report documents. Prepared source documents and entered in CRF systems. Collected and maintained study data according to protocol and Good Clinical Practices. Ensured protocol visits were scheduled and completed within parameters specified by protocol. Communicated doctor’s orders regarding dose adjustments to patients. Called insurance companies to obtain prior approval of specialty medications. Inventoried drug and lab kits. Trained in handling Investigational Product, temperature excursions, dispensing drug, and performing and

documenting drug accountability. Demonstrated competency in: administering EKGs, blood draws, specimen processing, specimen shipping,

and knowledge of disease processes and treatment.



Department of Psychiatry, UT Health Science Center, San Antonio, TexasClinical Research Coordinator (Social Science Research Associate III), 2008 – 2009

Coordinated advertisements – submitted for IRB approval, communicated with all media sources (tv, print, radio), negotiated advertising schedules (FOX, Express News, San Antonio Current, Cox radio stations, Clear Channel radio stations), submitted ad invoices, and analyzed responses to advertisements.

Also helped coordinate production of tv commercials with UT media department. Submitted invoices of advertisements for payment processing within the UT Health Science Center. Submitted protocols for full-board review to the UT Health Science Center IRB. Pre-screened and documented calls from interested participants. Also analyzed response pattern to ads. Ensured and facilitated completion of all staff training required per pharmaceutical companies. Scheduled all patient visits and doctor assessments. Performed protocol assessments (vitals, labs/blood draws, urine specimens, ECGs). Maintained all patients’ study documents, consents, and records. Processed lab specimens and shipped to central laboratories. Communicated with sponsors, local mental health clinics, and physicians regarding patients’ healthcare.

Discussed patients’ cases with medical doctors, psychiatrists, psychologist, and counselors. Conveyed to doctors/Principal Investigators patients’ symptoms and reactions to treatment. Resolved data queries in various CRF systems to ensure accurate collection of data.

Academic Center for Evidence-Based Practice, UT Health Science Center, San Antonio, Texas Research Associate (Social Science Research Associate II), 2005 – 2008

Educational Outreach: Helped in planning, delivering and evaluating a yearly Evidence-Based Practice research conference, providing Continuing Nursing Education and Continuing Medical Education credits to healthcare professionals.

Coordinated editing and printing of conference advertisements, brochures, and agendas with a team of medical professionals.

Prepared conference materials: coordinated mass printing of conference itinerary and 300+ page syllabi.

Also was responsible for compiling and printing the complete 300+ page syllabus of the conference for registrants.

Coordinated the production of an educational competencies podcast. Coordinated technical aspects of production with UT Health Science Center multimedia department.

EBP Research Competencies booklet for nurses: edited and helped compile. Applied for and received copyright registration. Also advertised for, tracked, and fulfilled purchase requests for the books

Assisted in training new employees and volunteers. Managed multiple research projects through all stages, from grant development to implementation and

completion. Maintained records of projects and created databases to track and organize studies. Assisted in preparation of and editing manuscripts, grant submissions, and lectures. Submitted studies to the UT Health Science Center IRB for approval. Once approved, organized approval

documents. Coordinated a multi-center research project, the ACE-Evidence Based Practice Readiness Inventory.

Provided templates to various university and hospital facilities to aid in IRB approvals at their institutions. Grant development activities included attending various collaborative meetings to discuss grant projects,

helping review budgets, and reviewing projected timelines.



Kelly Services - PPD, Inc. (Pharmaceutical Product Development), Austin, TexasTemporary Research Assistant, 2004 – 2005

Successfully completed Clinical Administration Foundation Training. Provided daily support to Project Manager, Clinical Team Manager and Clinical Research Associates on

several protocols, including international protocols.. Updated Clinical Research Associates' travel calendar. Maintained essential study documents per FDA regulations and filed according to PPD’s extensive SOPs. Mailed and faxed regulatory documents to sponsors, investigators and team members. Maintained study start-up databases and distributed to team. Scheduled and attended protocol meetings. Created and distributed meeting minutes.

NTI, Incorporated, Fatigue Countermeasures Lab, Brooks-City Base, TexasResearch Assistant, 2003 – 2004 Worked with civilians and military personnel in a neuropsychological company subcontracted with the government. Research areas included sleep deprivation and motor and cognitive performance.

Enhanced lab’s electronic logbook system allowing Principal Investigators to efficiently sort through large amounts of behavioral observation data.

Created comprehensive training manual to document staff training and standardize data-collection. Created Excel database with descriptions of over 90 scientific studies and their experimental designs. Edited Principal Investigator’s technical report and created tables of physiological data for publication. Participated in business development activities. Helped with proposal for Innovation Research grant. Administered physiological tests to subjects (Force Platform, Hand Dynamometer,vitals). Observed and recorded effects of sleep deprivation on computerized neuropsychological tests. Collected and entered data in source documents. Additionally organized, cleaned, reduced data in

preparation for analysis. Conducted literature and internet searches and obtained literature via interlibrary loan requests.

RESEARCH PROTOCOLS

A 6 month, Multicenter, Randomized, Stratified, Double-blind, Parallel group, study in Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old with Persistent Asthma

A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formotorol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma

A Randomized, Double-Blind, Parallel-Group Study of Cardiovascular Safety In Osteoarthritis or Rheumatoid Arthritis Patients With or at High Risk for Cardiovascular Disease Comparing XXXX with XXXX and XXX

A 2-week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6 to 11 Years with Seasonal Allergic Rhinitis

A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of XXX (Fluticasone Propionate Inhalation Powder) Administered Twice Daily compared with Placebo in Adolescent and Adult Subjects with Persistent Asthma Uncontrolled on Non-steroidal Therapy

A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of XXX (Fluticasone Propionate Inhalation Powder) Administered Twice Daily compared with Placebo in Adolescent and Adult Subjects with Severe Persistent Asthma Uncontrolled on High dose Inhaled Corticosteroid Therapy



A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety, And Dosing Regimens Of XXXX In Adults With Allergic Asthma Who Are Inadequately Controlled On Inhaled Corticosteroids And A Second Controller

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XXXX in Patients with Uncontrolled Asthma who are on Inhaled Corticosteroids and a Second Controller Medication

A Randomized Double-Masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-303 (0.075% Bromfenac in Durasite) to Durasite Vehicle in Cataract Surgery Subjects

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Trial of the Safety, Efficacy, and Pharmacokinetics of XXX Administered with Pegylated Interferon and Ribavirin in Treatment-Naïve Genotype 1 Patients with Chronic Hepatitis C Infection A Phase 3, Safety and Efficacy Study of XXX with PegIFN/RBV Chronic Hepatitis C Subjects Who Failed Prior Treatment with PegIFN/RBV

A phase 2, randomized, dose-ranging study to evaluate peg-interferon alpha-2a (Pegasys®) and Ribavirin with and without XXXXX in subjects chronically infected with hepatitis c virus

A Phase 2B Study of XXXX in Combination with Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who are Null or Partial Responders to Prior Treatment with Peginterferon Alfa plus Ribavirin Therapy

A Phase 2b Study of XXXXX in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects with Chronic Hepatitis C Genotype 1 and 4 Infection

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of XXXXXX Administered with Pegylated Interferon and Ribavirin in Genotype 1 Patients with Chronic Hepatitis C Infection

XXX in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (METS)

A Double-Blind Placebo Controlled Study of XXXX for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents with ADHD and Comorbid Dyslexia

A Phase 2 Study of XXXXX Compared with Placebo in the Treatment of Alcohol Dependence

XXXX for Treatment of Cocaine Dependence: A Phase II Study


CHARLTON_MATITA_RESEARCH CV_JUNE 2016

Documents

Transcript of CHARLTON_MATITA_RESEARCH CV_JUNE 2016