Jeanne Kleiman B.S., CCRP, ALC, CLC

adozno@r.postjobfree.com 513-***-****

EXPERTISE

Extensive experience in Clinical Research for over 15 years as a Research Coordinator and Research Study Manager. Conduction and collaboration with multi-institutional and multi-disciplinary teams to ensure study Protocol execution and integrity. Expert in regulatory affairs,submissions,amendments and study over-site. Provision of education and training to study staff and new staff orientation. A self-starter as well as leading a Team for a CDC funded study. Coordinating QA procedures to ensure quality data collection and verification to ensue data integrity and patient safety. Expertise in timely reporting deviations and development of action plans in accordance with protocols and teams to maintain protocol integrity. Creation of ICD and MOP's in accordance with Protocols. Proficient in study start up, recruitment, Protocol implementation and study close out.

PROFESSIONAL EXPERIENCE

Clinical Research Coordinator - Consultants for Clinical Research 2020 - 2021 NASH Clinical Trials - Management of study Protocol, recruitment, execution, GCP, quality and quantitative data, subject retention. Assurance of Protocol execution in compliance with regulatory policies and procedures.

Clinical Research Coordinator - Cincinnati Children's Hospital Medical Center (CCHMC) 1996 – 2016 Project Manager for CDC funded study - CCHMC 2016 - 2019 Management of Team of nine coordinators, 250 participants, multi-institutional and PI collaborations Personal Fitness Trainer - YMCA

Registered Medical Assistant

*Allergy & Asthma Center – Established solo practice in direct collaboration with Physician

*Internal Medicine - Alliance Primary Care – Coordination and communication with Physicians in patient care

*Cincinnati Children's Hospital Medical Center(Pediatrics) – 1993-1996 Provided clinical care and management of pediatric patients in collaboration with Physicians, Resident Physicians and staff

Early Childhood Educator and Director – Teacher and Mentor for diverse early childhood educational programs. Director for summer early childhood program – Managed program and staff EDUCATION

B.S. Maternal & Child Health - Union University - Cum Laude Registered Medical Assistant - Institute of Medical & Dental Technology, Honors Medical Laboratory Technician - Cincinnati State Technical College A.S. Early Childhood Education - University of Cincinnati – Cum Laude Northern Kentucky University - Special emphasis on Health, Nursing and Education MENTOR and TEACHER

Mentor & Supervisor of graduate and undergraduate students. Training in Study Trial Design, Study Protocols. Institutional Mentor for clinical research coordinators for Clinical Research advancement program at Cincinnati Children's Hospital Medical Center.

PROFESSIONAL ORGANIZATIONS/CERTIFICATIONS

CITI and GCP certifications - Up to date

Society of Clinical Research Associates (SoCRA), October 2013 – Present American Society for Parenteral & Enteral Nutrition (ASPEN), 2013 – 2014 Advanced Lactation Consultant - Academy of Lactation Policy and Practice - 2012 - Present Certified Lactation Counselor- Academy of Lactation Policy and Practice - 2006 - Present Registered Medical Assistant – American Medical Technologists VOLUNTEER AFFILIATIONS

Director, Teacher and Mentor- Diverse children's programs School Health Council - Revised guidelines for School Health curriculum Nurses for Community Education - Fetal reproductive education for diverse population of young adults in public health education system

Jeanne Kleiman B.S., ALC, CLC, CCRP

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PUBLICATIONS/PRESENTATIONS

Presenter: Cincinnati Children's Hospital Medical Center Clinical Research Professionals State of the Union - March 12, 2013

Randomized Controlled Trial of Dietary Docosahexaenoic acid (DHA) in Midwestern Women, Poster presentation

Presenter: ASPEN - Annual conference Feb 2013

Using the Pea Pod® in Nutritional Assessment. Round table presentation Effects of novel hydrolyzed protein post discharge formula on preterm infant body composition and growth outcomes, Poster presentation Publication: The Effect of Hydrolyzed Protein on Body Composition in Preterm Infants GLOBAL RESEARCH

Global Human Milk Research Collaborative for the Longitudinal Study of Human Milk Composition and Child Health Outcomes (Global Human Milk Study) USA & Mexico Comparison of Enteral Feeding of Preterm Infants between Cincinnati University Hospital and Peking Union Medical College Hospital

RESEARCH EXPERIENCES – Clinical Research Coordinator Cincinnati Allergy Prevention (CAP) - Interventional Study Health Outcomes & Measurements of the Environment - Randomized Controlled Blinded study Research Human Milk Bank - Establish a bank of voluntarily donated milk samples for research In f ant Feeding Study - Designed to improve early breastfeeding outcomes for breastfeeding mothers Cincinnati Breastfeeding Cohort (CBC) - Longitudinal study Antidepressant Use in New Mothers - Pilot Trial

Follow up to Biochemical Indicators of Lactogenesis & Infant Feeding Study - Longitudinal follow up including study participants from both studies

Post Discharge Formula Study for pre-term infants (Industry sponsored) Multi-Center Randomized Control Blinded Trial of pre-term infants responses to a new commercially available discharge formula Docosahexaenoic acid (DHA) supplementation to mothers to improve Preterm Infant nutrition and Immune Homeostasis – FDA Clinical Trial-Prospective Randomized Controlled Blinded Trial Multiple diverse Neonatal Intensive Care Unit (NICU) Research studies within CCHMC and UCMC Neonatal Research Network (NRN)

Pediatric Trials Network: Ensuring Accurate Weight Assessment in Newborns and Young Infants CISA LAIV4 Asthma Study – Randomized control trial Project Manager

PREVAIL Cohort: Pediatric Respiratory & Enteric Virus Acquisition and Immunogenesis Longitudinal Cohort

(CDC Sponsored) Longitudinal cohort study (observational/non-interventional) Natural history of infection and immunity from late pregnancy to two years of life

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