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Deborah Ann Culliton-Tolenaar
New York City, NY
deb@painterly.net
http://www.painterly.net


Current and Past Exhibitions:
  1. 2010 (Oct 7 - Jan 31, 2011) - Group Show
    20th Medical Center Art Show
    Honorable Mention

  2. 2003 (September 14) - Group Show
    Art-in-the-Park at Park LaBrea

  3. 2001 (May 12 - June 17) - Group Show
    BWAC Pier Show 9

  4. 2001 (May 19-20) - Studio Tour
    BWAC Park Slope Studio Tour

  5. 2001 (May 4-7) - Group Show
    BWAC Small Works Show
    Kentler International Drawing Space

  6. 2000 (Oct - Dec) - Group Show
    BWAC - Small Works Exhibition
  7. 1999 (May) - Group Show
    Art Students League - Charles Hinman's Class Exhibition
  8. 1998 (December) - Group Show
    Art Students League - Christmas Exhibition
Professional
Artists Organization:
 

EXPERIENCE:

Population Council - New York, New York
Clinical Project Manager, HIV & AIDS Program (June 2009 - Present)
Center for Biomedical Research:

  • Responsible for implementation and oversight of key operational aspects of the HIV & AIDS Program, Microbicide early phase global clinical trials.
  • Contract review and negotation.
  • Development and management of clinical budgets and assigning resources.
  • Ensure operation of clinical studies in accordance with ICH GCP guidelines.
  • Responsibilities include participation in design and writing or protocols and informed consent forms; creation of investigator brochure; developing and maintaining SOPs.
  • Liaising with Regulatory, Legal, Safety and Product Development/Pre-Clinical Teams
  • Site training on GCP, ethics and source documentation.
  • Supervising/mentoring study coordinators.
    TA: Infectious Diseases

Baxter Healthcare, Inc - Westlake Village, California
Manager, Clinical Operations, GCMA (October 2006 - May 2009)
Baxter Bioscience:

  • Responsible for the management of Phase 4 global post-marketing research projects including coordination of study concept document, protocol and case report form development.
  • Manage site selection process and site contract negotitation.
  • Review site IRB submissions and collection of regulatory documents.
  • Manage external team activities including vendor/CRO management.
  • Ensure SAEs reported in timely fashion; monthly SAE reconciliation with study database.
  • Responsible for assuring adherence to protocol timelines and budget tracking.
  • Development of study documents with multi-disciplinary team (protocol, CRFs, POM, SAP, SWP, DMP).
  • Creation and maintenance of global study project dashboards.
  • Tracking and updating study metrics for dissemination to key stakeholders.
  • Communication with study investigators and sites; ICF review
  • Represent Medical Affairs in the support of product information booths at scientific meetings.
  • Responsible for report writing and ensuring CRO/site compliance with FDA/EMEA requirements related to the project.
    TA: Hemophilia

Baxter Bioscience - Westlake Village, California
Project Manager, Medical Information (April 2006 - October 2006)
(Kelly Scientific contrator) Baxter Bioscience:

  • Customer facing position in Medical Affairs, responsible for providing medical and scientific information to external customers and internal colleagues relating to specific licensed products.
  • Develop standard response letters.
  • Interface with Sales, Marketing, Regulatory Affairs, Legal, Quality Assurance, Quality Control, Clinical Development, Research and Development, Manufacturing and Plasma Operations on specific licensed products.
  • Represent Medical Affairs in the support of product information booths at scientific meetings.
    TAs: Immunology, Hemophilia, Pulmonology, Critical Care

Pathway Diagnostics - Malibu, California
Clinical Project Coordinator (December 2005 - March 2006)
(Aerotek contractor 12/05-2/06, FTE 2/06-3/06)

  • Responsible for the daily management of clinical studies, including the transcription and maintenance of in-process data, coordination of specimen testing, reporting of results to clients/sponsors and ensuring regulatory compliance of studies.
  • Ensure timely and accurate data dissemination to clients.
  • GLP training.

AMGEN - General Medicine - Thousand Oaks, California
Clinical Trial Specialist II, General Medicine (April 2005 - October 2005)
(ACT1 contractor):

  • Under supervision of Clinical Research Management, coordinate the activities associated with the evaluation, initiation and management of Clinical Development clinical trials.
  • Review consent forms for accuracy.
  • Coordinate Chart Review Program for nephrology protocol.
  • Communicate issues with team and liaison with various departments and vendors to resolve issues.
  • Identify barriers to enrollment, including weekly follow-up with site staff.
  • Identify potential new sites for protocol implementation.
  • Site selection for Phase 2 bioequivalence study.
  • Create site tools for new protocol and create pre-study site questionnaire.
  • Create Access database for tracking site selection and initiation activity.
  • Create slide decks for training field monitors and for investigator's meeting presentation.
  • Resolve budget issues.
  • Maintain expertise through familiarity with clinical and scientific literature and participation in professional activities.
    TA: Renal

UCLA Medical Center, CARE Center - Los Angeles, California
Site Coordinator, Clinical Research Coordinator (March 2003 - March 2005)
AIDS Clinical Trials Group:

  • ACTG UCLA Site Coordinator since 6/04.
  • Responsibilities include providing assistance and supervision to two subunits of UCLA.
  • Oversight of data management, laboratory and recruitment/outreach related to ACTG studies.
  • Administrative duties related to ACTG including correspondence with Regulatory Coordination Center (RCC) and Site Operations Center (in association with DAIDS).
  • Communication and dispersal of information sent via RCC and Ops to subunits and all staff.
  • Summarize SAE reports and distribute to clinical personnel.
  • Management and coordination of multiple protocols (NIH-DAIDS sponsored ACTG and industry) at the Center for Clinical AIDS Research and Education.
  • Perform protocol required clinical assessments, determine eligibility of subjects for protocols and maintain adherence to protocol requirements.
  • Develop/create protocol templates for new studies.
  • Coordinate research with physicians and ancillary departments.
  • AE and SAE reporting.
  • Quality management and quality assurance.
  • Troubleshoot barriers to enrollment.
  • Oversee Data Management ; liaise with Lab Director and Outreach Coordinator.
  • Completion of case report forms and source documentation.
  • Experience with Phase 1 - 4.
  • Certification acquired in Gene Therapy Research and Human Subject Research.
  • Thorough knowledge of GCP, HIPAA regulations.

New York University Medical Center - New York, New York
Systems Analyst / Clinical Data Manager (February 1998 - February 2003)
AIDS Clinical Trials Group:

  • Coordination and supervision of the database management team on the AIDS Clinical Trial Unit (ACTU).
  • Quality management and quality assurance of data.
  • Develop systems to manage data - create and implement QA tools.
  • Management of case report forms (CRF) and organization of protocols.
  • Retrieve lab results and review for AEs/SAEs.
  • Responsible for accuracy and completeness of data, including resolving logic checks and queries.
  • Responsible for thorough knowledge of assigned protocols and creating visit sheets with required evaluations for staff.
  • Computer set-up, maintenance and software technician.
  • Test, troubleshoot and make recommendations for new utilities and applications.
  • Assist and train staff in computer-related issues.

Mount Sinai Medical Center - New York, New York
Clinical Research Coordinator (August 1995 - February 1998)
Department of Neurology:

  • Management of research protocols, including clinical interviews, neuropsychological testing, creating forms for protocols, database management, blood processing and storage.
  • Research protocols include Parkinson's Disease (PD) and AIDS populations.
  • Responsible for grant submissions and reporting to NIH, FDA and IRB.
  • Responsible for organizing patient resources and expanding development of Parkinson's Disease Center.
  • Initiator and leader of PD Support Group, arrange for speakers, advertise.
  • Clinical coordinator responsibilities include interviewing patients for present complaints and medications and taking vital signs prior to clinical visit with neurologist (Melvin Yahr, MD)

Mount Sinai Medical Center - New York, New York
Grants Manager / Clinical Research Coordinator (May 1990 - August 1995)
Department of Psychiatry:

  • Responsible for preparation and submission of grants to various funding agencies.
  • Coordination of research protocols at Mount Sinai's Schizophrenia Research Unit and affiliate hospitals.
  • Conducted structured clinical interviews, administered clinical rating scales, and neuropsychological tests.
  • Supervised and trained research assistants; trained residents and ancillary staff on conducting protocols, use of various clinical rating scales and interviews.
  • Library research and blood processing.

Stony Lodge Hospital - Briarcliff Manor, New York
Mental Health Associate (May 1988 - March 1990)
Adult Psychiatric Unit:

  • Performed patient care duties and selected services under the supervision of the Registered Nurse in charge.
  • Worked primarily on the Adult Psychiatric Unit with rotations to Adolescent Unit, Dual Diagnosis Units and Admitting Unit.
  • Developed and led Life Story Group and Peer Evaluation Group.
  • Coordinated daily assignment schedule.

New York Hospital - Cornell Medical Center - White Plains, New York
Clinical Research Assistant (Volunteer) (July 1987-May 1988)

  • Collected data from patients and conducted library research for pilot study: "The Neuropsychology of Metabolic Encephalopathies."
  • Administered neuropsychological tests.

EDUCATION:
  1. Queens College, C.U.N.Y. - Flushing, New York
    Masters Program, Psychology
    (
    Ph.D. Program, Clinical Neuropsychology Track - 36 credits)
  2. Westchester Community College - Valhalla, New York
    Basic Sciences
  3. Mercy College - Dobbs Ferry, New York
    B.A., Psychology
  4. College of New Rochelle - New Rochelle, New York
    Fine Arts
  5. Westchester Community College - Valhalla, New York
    A.A.S., Fine Arts


    ART

  1. Art Students League - New York, New York
    Studio class (painting)
    Study with Charles Hinman
  2. Dragonfly Stained Glass - Canoga Park, CA
    Studio class (stained glass).
    Study with Larry Joers
  3. Manhattan Stained Glass - New York, New York
    Studio class (stained glass)
    Study with Tommy Giambusso

 


Publications:
  1. Kaminski, R., Moriarty, T., Wolf, D., Culliton, D., Bodine, J., Davidson, M. and Davis, K.L. (1991). Famotidine, a histamine H2 receptor antagonist and negative symptoms of schizophrenia. Biological Psychiatry, 29, 67-68.
  2. Hirschowitz, J., Hitzemann, R., Kaminski, R., Mann, M., Piscani, K., and Culliton, D. (1993). D2 receptor occupancy and optimum antipsychotic dose. APA Annual Meeting, San Francisco, May 22- 27. (Symposium).
  3. Kaminski, R., Di Rocco, A., Molinari, S., Culliton, D., Yahr, M. (1994). Treatment of bradyphrenia with famotidine, a histamine H2 receptor antagonist. New Trends in Clinical Neuropharmacology, Vol. VIII, Jan-Mar, 306. (Abstract presented at the 11th International Symposium on Parkinson's Disease, Rome, Italy).
  4. Hirschowitz, J., Hitzemann, R., Piscani, K., Burr, G., Frecska, E., Culliton, D., Mann, M. & Curtis, C. (1997). The dose reduction in schizophrenia (DORIS) study: A final report. Schizophrenia Research, 23, 31-43.
  5. Negrier, C. Fleury, R., Hoots, K., Gajek, H., Berg, R., Stephens, D., Tolenaar, D. (2008). Surgical interventions with FEIBA (SURF) - studying the feasibility of surgery in inhibitor patients. Abstract presented at WFH 2008 World Congress, Istanbul, Turkey.
  6. Negrier, C. Fleury, R., Ha Noh, J., Baghaei, F., Claeyssens, S., Yee, T., Gajek, H., Tolenaar, D., Stephens, D. (2009). The use of FEIBA during surgeries in hemophilia patients with inhibitors: update from SURF international registry. Abstract presented at ISTH 2009 World Congress, Boston, Massachusetts.

Guest Lecturer:

"Where Has All the Thinking Gone: A Lecture on Frontal Lobe Dysfunction." Presented to the Treatment Resistant Disorders Symposium, Department of Biomedical Science, The University of Sheffield, UK. 1993


Qualification Summary:

Clinical Trials Phase 1 - 4. Website designer since 1997, PC, Windows, Microsoft Office, eClinical, eData, EDC, Corel Photopaint, Adobe Photoshop, Macromedia Dreamweaver, WS FTP, Telnet, QVT, HTML coding, hardware maintenance and software installation.


References:

Furnished upon request.