GLADYS TATAW-AYUKETAH, PhD, MPH, RN

410-***-**** ~ adxjpl@r.postjobfree.com

LinkedIn.com/in/gladys-tataw-ayuketah-222477b1

Professional Summary: Over 30 years of nursing and clinical research oversight, 15 years in planning, managing, organizing and evaluating a clinical research program. Have served as Associate Investigator on several clinical trials related to health disparities, community health, minority health, public health, and integrative health. Supervising cross-functional and multidisciplinary teams. Managing the budget and leading strategic and operational planning to include the development of short, and long-term goals.

Core Competencies:

Data Management

Project Management intramural and extramural

Knowledge of IRB ethical requirements

Protocol Development/Study Design

Qualitative / Quantitative Data Analysis

Planning, managing, analyzing and evaluating health research programs

Work Experience:

Clinical Research Program Manager (GS-13), Metabolic/Obesity Research

National Institutes of Health 12/2010 to present

Major Duties and Responsibilities

Planned, developed, and implemented policies and criteria for the administration of the metabolic clinical research program

Developed standard of practices/procedures/processes to prevent and track adverse outcomes related to data collection and storage.

Developed training material; trained staff on protocol specifications per IRB and provided technical advice to multiple institute investigators on clinical trials requirements.

Reviewed and analyzed projects submitted by staff on quality improvements, standard of practices, abstracts, and posters, for validity, adequacy, and consistency of content.

Facilitated meetings with multiple stakeholders within the Clinical Center/NIH and prepares reports on progress of clinical trials within the clinical research program.

Reviewed adverse events, and analysis and assured timely reporting.

Maintains data and trained personnel logs to ascertain consistency in practice. Creates spreadsheets for data tracking purposes.

Reviews completed work by staff for accuracy and consistency with policies and appropriateness per study protocols.

Day to day administrative functions

Managing conflict and problem-solving competencies

Assures and participates in proper administration of the Informed Consent process and in accordance with the Office of Human Subjects Protection and bioethical principles.

Nurse/Program Management (Acting, GS 14), Metabolic and Obesity Research- National Institutes of Health 12/08 to 12/2010

Key accomplishments

Created recruitment, competency assessment for unit. Managed resourcing and the budget, and accountable supervisor for all hiring / personnel actions.

Created unit-based roles; unit-based education coordinator, core team leader for cross coverage, and competency evaluation to support the varied programs on the unit.

Major Duties and Responsibilities

Designed and managed a clinical care delivery model to assure both clinical expertise and protocol knowledge to support the sub-specialties, and the availability of generalist staff that can cross cover in all areas.

Monitored performance and evaluated program performance are met both within and across sub-specialty teams to ensure improvements in program operations.

Managed daily program operations through planning, coordinating, and managing unit workgroups/representatives for Shared Governance committees

Established priorities for oversight of the clinical research program, and provided guidance to ascertain GCP and IRB compliance.

Assessed potential scientific and administrative issues and problem solved or escalates in a timely manner

Managed a culturally diverse group of staff from multiple clinical/research practice areas into a cohesive team of research nurses focused on studying complex obesity dynamics.

Identified opportunities and problem areas, research gaps/performance improvement opportunities, relevant program needs, and makes recommendations

Participated in program strategic and operational planning including the development of short/long range goals and objectives

Managed program budgets for personnel and supplies

Clinical Research Nurse/Educator (GS 12), Metabolic and Obesity Research

National Institutes of Health 10/ 2006 – 12/2008

Major Duties and Responsibilities

Maximized nursing teamwork on the unit and supports the integration and effective practice of the multidisciplinary team.

Day to day management of the clinical research program/projects

Fosters cooperation, communication, and consensus among groups.

Established standard operating procedures and specific guidelines to assure consistency in Unit processes, good clinical practice, and standardization in practice while optimizing data collection for a diverse portfolio of clinical trials.

Administered clinical trials in compliance with the protocols and collaborates on remedial actions when needed.

Managed and educated clinical staff on the integration of research and practice incorporated into daily patient care

Capacity building through networking, hiring, and training a multidisciplinary team to implement the metabolic clinical research program that was newly established at the NIH

Director Health Education and Health Promotion, University of CA, Irvine Medical Center - 1999-2001

Conducting needs assessment, directing improvements and enhancements to the database, monitoring progress toward accomplishment of milestones, and confirming completion and utility of the database and reports generated from the database.

Participating in program strategic and operational planning including the development of short/long range goals and objectives

Ensured that strategic plan milestones were achieved.

Operationalization of the day to day activities of the program

Developing metrics to evaluate the impact of the program and their major focus areas

Interacting with senior officials from the UCI medical center and management in resolving or planning new initiatives

Managing all aspects of the Grant award process including receipt, implementation, oversight of funding decisions, expenditure and outcomes

Promoted and supported multidisciplinary research on the understanding of how individual, social, environmental, and biological determinates affect health status, access, and quality of health care in minority and vulnerable populations across their lifespan

Analyzing and evaluating the productivity of the program by reviewing the annual reports

Professional Development:

Research Assistant/MPH Practicum (11/2009-6/2010) - 03-CC-0301 Health Beliefs and Health Behavior Practices, Including Complementary and Alternative Medicine Use, Among Minorities with Rheumatic Disease

Thematic analysis of community leader and participant generated data.

Collaborated in writing and editing the manuscripts.

Managing the annual scientific review process

Promoted and supported multidisciplinary research on biological and behavioral mechanisms and pathways to resilience and susceptibility to adverse health conditions

Research Assistant/MPH Practicum (11/2009-2014) - 07-CC-0011 Hypnosis as a Pain and Symptom Management Strategy in Patients with Sickle Cell Disease

Participant recruitment, data collection, patient education, preparation for hypnosis sessions, face-to-face interviews, and monitoring self-reported data (pain diaries).

Ensuring good clinical practice and compliance with IRB specifications

Shared responsibility of the clinical study regulatory and administrative aspects

Managing and organizing information on an ongoing basis

Developed recruitment brochures and contributed to the content for the project website

Associate Investigator (1/2011-2019) - T-CC-0066 Pilot Study of Yoga as Self-Care for Arthritis in Minority Communities

Collaborated in protocol development, study design and implementation.

Data collection, management, and analysis

Collaborated in qualitative and quantitative data analysis process.

Review and editing final drafts based on feedback from Scientific Review and IRB continuing review process.

Collaborated in closing out the study and submitting to Clinical trials.gov.

Associate Investigator: Qualitative analysis role (Original protocol - A community feasibility study of a cooking behavior intervention in African-American adults at risk for cardiovascular disease: DC COOKS (DC Community Organizing for Optimal culinary Knowledge Study) with Heart

Collaborating in Phase 1 thematic analysis of the 5 focus groups based on the published original protocol

Public Health Outreach and Consultation:

Led planning and implementation of community flu clinic for the Bowie Community in Prince Georges County, MD

Provided consultation and coordinating Emergency Management Preparedness for the community monthly meetings, fire and disaster drills, education on preparedness and provision of emergency kits.

Participation in a multidisciplinary process to implement weekly physical activity sessions for Prince Georges County community members.

Special Assignment (GS 13), volunteer to support COVID 19 mission

Department of Health and Human Services, US 03/2021-07/2021

Temporary assignment to support Operation Warp Speed/International Coordinating Center Initiative for COVID 19 therapeutics

Supporting investigators/research teams on completing the Multicenter clinical trials on the INSIGHT ACTIV-3 therapeutic candidates for COVID 19 inpatients and outpatients who are asymptomatic and symptomatic patients.

Clinical Trial Specialist/Study Management for immunotherapy strategy for hyperimmune intravenous immunoglobulin for patients with COVID 19

Clinical Trial Manager – ICON Health Solutions, Consulting in Preclinical through phase IV Clinical Research and Clinical Trial Services for drugs and services globally and in the US 08/2012

Evaluated potential risks for patient safety and the adequacy of Safety Monitoring Plans

Ascertain regulatory and monitoring milestones are met

Manage multidisciplinary team members and interactions with clinical data science and management team, pharmacovigilance team, regulatory affairs, quality assurance throughout the lifecycle of the clinical trial

Define and monitor project scope from initiation to close out

Clinical oversight of site monitoring

Assure timelines, milestones and deliverables are met

Manage resources and aligned with the budget

Manage portfolios of research projects

Participate and lead in the design and reviewing study documents, logs, case report forms, Inform Consent Forms, budgets and proposals

Assist with IRB submissions and issues

Ensure compliance with sponsor and client standards

Managed workload and project priorities to fulfill the mission of the global scientific program

Fostered innovative collaborations and partnerships through multiple dashboards and systems

Education:

PhD Public Health/Epidemiology – Walden University, Minneapolis, MN 2022

Independent research in obesity disparities – Dissertation title “Exploring Promotoras as Influencers of Acceptability and Participation in Physical Activity and Dietary Modifications Among Latino Women”

Master of Public Health – Walden University, Minneapolis, MN 2010 – Health Disparities Portfolio

Bachelor of Science in Nursing – Excelsior College, Albany, NY 2006

Bachelor of Science in Health Sciences - Community Health Education - California State University Long Beach, CA- 2001

National Institutes of Health Grants Management course through the OER staff training 2010

Professional Affiliations, Licensure and Certifications:

Registered Nurse - MD License

CPR certified – American Heart Association

American Public Health Association

American Nurses Associations

Publications/Abstracts:

Wallen, G.R., Middleton, K.R., Miller-Davis, C., Tataw-Ayuketah, G., Todaro, A., Rivera-Goba, M., Mittleman, B. (2012). Rheumatic Disease Patients, Community Leaders and Health Behavior Researchers: Partners in Research. Progress in Community Health Partnerships: Research, Education, and Action, 6(4), 405-415.

Wallen, G.R., Middleton, K.R., Miller-Davis, C., Tataw-Ayuketah, G., Todaro, A., Rivera-Goba, M., Mittleman, B. (2012). Patients’ and Community Leaders’ Perceptions Regarding Conducting Health Behavior Research in a Diverse, Urban Clinic Specializing in Rheumatic Diseases. Progress in Community Health Partnerships: Research, Education, and Action, 2012:6(4):405-15. doi: 10.1353/cpr.2012.0052.

Middleton, K.R., Wallen, G.R., Ward, M., Tataw-Ayuketah, G., Acevedo, A., Dietz, L., Mittleman, B., Velummylum, S., Monaz, S., & Fike, A. (2013). A Pilot Study of Yoga as Self-Care for Arthritis in Minority Communities. Health Quality of Life Outcomes, 2013:11, 55.. https://doi.org/10.1186/147*-****-**-**

Middleton, K.R., Wallen, G.R., Tataw-Ayuketah, G., Andrade, P., Mittleman, B., Monaz, S., & Fike, A. (Nov, 2014). Personal Narratives to Assess Acceptability of Yoga for Self-Care in Minorities with Arthritis. APHA 2014 Conference Paper

Middleton K. R., Haaz Moonaz S., Hasni SA, et al. Yoga for systemic lupus erythematosus (SLE): Clinician experiences and qualitative perspectives from students and yoga instructors living with SLE. Complement Ther Med. 2018;41:111-117. doi:10.1016/j.ctim.2018.09.001

Middleton, K. R., Ward, M. M., Haaz Moonaz, S., Magaña López, M., Tataw-Ayuketah, G., Yang, L., Acevedo, A. T., Brandon, Z., & Wallen, G. R. (2018). Feasibility and assessment of outcome measures for yoga as self-care for minorities with arthritis: a pilot study. Pilot and feasibility studies, 4, 53. https://doi.org/10.1186/s40814-018-0248-

Middleton, K. R., Magaña López, M., Haaz Moonaz, S., Tataw-Ayuketah, G., Ward, M. M., & Wallen, G. R. (2017). A qualitative approach exploring the acceptability of yoga for minorities living with arthritis: 'Where are the people who look like me?'. Complementary therapies in medicine, 31, 82–89. https://doi.org/10.1016/j.ctim.2017.02.006

GO. Tataw-Ayuketah, BSHE, RN; KR. Middleton, MPH, RN; GR. Wallen, PHD, RN. “Examining the Relationships Between Obesity, Functional Disability and Pain Intensity in Minority Patients with Rheumatic Diseases” at the 19th Annual USPHS Nursing Recognition Day May 7, 2010 in Bethesda, MD.

GO. Tataw-Ayuketah, MPH, RN, et al. The Metabolic Clinical Research Unit: A Multifaceted Approach to Obesity Epidemic at the International Association of Clinical Research Nursing Nov 7, 2017 conference

GO. Tataw-Ayuketah, MPH, RN; IR. Rozga, BSN; KM. Feigenbaum, MSN, RN. Reducing Hemolysis and Improving Data Collection in Obesity Research within The Metabolic Clinical Research Unit at the International Association of Clinical Research Nursing Oct 18, 2017 conference

Awards:

National Institutes of Health Director’s Award for Directing Patient Care 2008/2015

Preceptor Award 2009, NIH

Languages:

Fluent in French and English

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