SUSAN M. SINCLAIR PHD, MPH, RN, FNAP Professor, Clinical ...

SUSAN M. SINCLAIR, PHD, MPH, RN, FNAP

Professor, Clinical Research Program, School of Nursing College of Health and Human Services University of North Carolina Wilmington

601 South College Road Wilmington, NC 28403 Sinclairs@uncw.edu (910) 962-3802

EDUCATION

1996

1990

1982

University of North Carolina at Chapel Hill, Chapel Hill, NC School of Public Health Ph.D., Epidemiology

Columbia University, New York, NY School of Public Health M.P.H., Environmental Sciences

East Carolina University, Greenville, NC School of Nursing B.S.N., Nursing

LICENSE AND CERTIFICATION

2011 ? present 2009 ? present 2005 ? present 2004 ? present 1982 ? present

Protection of Human Subjects Training for IRB Members, CITI FDA Annual Ethics Training for Special Government Employees ICH E6 Good Clinical Practice (various providers) Protection of Human Subjects Training, CITI Registered Nurse in North Carolina: Cert. No. 80065. Expires 9/30/19

PROFESSIONAL EXPERIENCE

University of North Carolina Wilmington, School of Nursing, Wilmington, NC

2017 ? present

Professor

2012 ? June 2017

Associate Professor

2006 ? June 2012

Assistant Professor

? Promote and improve evidence-based practice in women's health through dissemination of pregnancy registry research data and advancement of pregnancy registry research methodologies.

? Conduct independent research in pharmacoepidemiology, medication safety during pregnancy, and clinical study methodologies surrounding the development of new medications and devices.

? Serve in teaching, advising, and administrative roles in undergraduate and graduate programs in Clinical Research and doctoral program in Nursing.

? Serve in numerous leadership roles on committees in the School of Nursing and at the university level, including the University's Faculty Hearings Panel.

? Served as the Faculty Chair of the School of Nursing, 2015-2016.

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Susan M. Sinclair PhD, MPH, RN, FNAP

Syneos Health, Wilmington, NC

2006 to present

Senior Advisor ? Real World & Late Phase

2004 ?2006

Associate Director - Registries & Epidemiology

? Provide consultation to pharmaceutical companies in the areas of epidemiology and pharmacoepidemiology, with emphasis on national and global pregnancy exposure registries.

? Design post-marketing clinical research studies and registries, including development of study protocol, data collection forms, and statistical analysis plan.

? Oversee 11+ pregnancy registries and other post-marketing studies as principal investigator or lead epidemiologist; support study team including project managers, data managers, biostatistician, medical writers.

? Monitor pregnancy registry data for safety signals; provide scientific input from epidemiologic perspective.

? Participate in proposal development, business development, and marketing activities.

PPD Inc., Wilmington, NC 2003 ? 2004 2002 ? 2003 2000 ? 2002 1998 ? 2000

Acting Director, Health Outcomes Associate Director, Health Outcomes Senior Pharmacoepidemiologist, Health Outcomes Biostatistician/Epidemiologist, Biostatistics

? Provided consultation to pharmaceutical companies related to the design and conduct of clinical trials and post-marketing studies.

? Developed statistical analysis plan and oversee development of data collection forms and programming for statistical analysis of clinical trial data.

? Managed all aspects of operating unit to ensure high quality deliverables related to the design and conduct of biostatistics, health outcomes, pharmacoeconomic, and pharmacoepidemiologic research. (i.e., protocols, statistical analysis plans, statistical analysis, reports and manuscripts).

? Developed study protocols for post-marketing studies; advise on study protocols for clinical trials. ? Participated in proposal development, business development, and marketing activities.

University of North Carolina at Chapel Hill, Department of Epidemiology, Chapel Hill, NC

1999 to 2001

Part-time Instructor

? Taught one section of an annual 10-week introductory epidemiology online course supported by UNCChapel Hill for students in the Physician's Assistant program at Duke University and East Carolina University.

Centers for Disease Control and Prevention

National Institute for Occupational Safety and Health (NIOSH), Morgantown, WV

1996-1998

Epidemic Intelligence Service (EIS) Officer

Lieutenant Commander - Public Health Service

? Conducted epidemiological research pertinent to occupational safety and health issues. ? Led in the development of an active surveillance system for silicosis, based mortality data from the

National Vital Statistics System, National Center for Health Statistics.

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Susan M. Sinclair PhD, MPH, RN, FNAP

? Analyzed data from the NIOSH's database from the Coal Workers' Health Surveillance Program to estimate total burden of lung disease among coal workers.

? Disseminated research findings to the public, researchers, public health officials, and health care practitioners as a representative of the Centers for Disease Control and Prevention.

? Presented research findings through scientific manuscripts and presentations. ? Participated in health-related occupational work-site investigations. ? Served as Lecturer for occupational medicine residents on silicosis surveillance and 1st year medical

students in epidemiology course at West Virginia University, School of Medicine.

DePaul Hospital - Home Health Services, Norfolk, VA

1993-1996

Home Health Nurse

? Provided home health nursing services including physical, mental, and psychosocial assessments. ? Administered nursing care, provided referrals for unmet psychosocial, medical, and financial needs. ? Coordinated patient care across disciplines.

University of North Carolina at Chapel Hill, Chapel Hill, NC

1991-1993

Graduate Research Assistant

? Provided research support for the Health and Clean Air Study ? a 3 year, 6-community epidemiological study of the respiratory health effects associated with living near a hazardous, biomedical, or municipal waste incinerator.

? Developed data collection tools: questionnaires, peak flow diaries, instructional videos for subjects. ? Analyzed data using multiple linear regression and general linear mixed modeling. ? Disseminated findings in manuscripts and presentations at scientific meetings. ? Interacted with community residents regarding the sensitive public health issue of living in an

incinerator community.

NC Department of Environment, Health, And Natural Resources, Raleigh, NC

1992

Project Coordinator, Lyme Disease Surveillance Study

? Conducted active surveillance for Lyme disease in NC. ? Performed educational outreach to physicians and county health departments regarding the diagnosis,

treatment, and prevention of Lyme disease. ? Worked with CDC in attempt to obtain a positive skin biopsy culture for B. Burgdorferi by distributing

culture media to physicians and encouraging skin biopsies for erythema migrans. ? Communicated results in the state's health communication publication.

North Carolina Memorial Hospital, Chapel Hill, NC

1990-1992

Intensive Care Staff Nurse, Neurosurgery ICU/Cardiovascular ICU

? Delivered high quality nursing care to critically ill neuro-surgical/neuro-trauma and cardio-thoracic surgical patients including patients on intra-aortic balloon pump and patients in the first 24 hours postbilateral lung transplant.

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Susan M. Sinclair PhD, MPH, RN, FNAP

Natural Resources Defense Council (NRDC), New York, NY

1986

Research Assistant

Summer practicum for Columbia University MPH program.

? Received calls and queries from the public related to environmental exposures (e.g., air and water quality, pesticides) for the Toxic Substances Information Line.

? Conducted research to address calls and queries, including animal and human toxicology data, epidemiologic studies, and regulations.

? Summarized available evidence and provide regulations as written responses from the NRDC.

Memorial Sloan-Kettering Cancer Center, New York, NY

1984-1990

Staff/Supervisory Intensive Care Nurse

? Provided nursing care to critically ill cancer patients (pediatric and adult). ? Supervised 10-15 registered nurses and nursing assistants in the ICU. ? Responsible for the care administered to 10 critically ill patients per shift, staff evaluations, educational

seminars, staff scheduling, and recruiting.

HONORS AND AWARDS

2018

Distinguished Scholar and Fellow National Academies of Practice, Nursing Academy

2018

University of North Carolina, Board of Governors 2018 Award for Excellence in Teaching University of North Carolina Wilmington

2017

Chancellor's Teaching Excellence Award University of North Carolina Wilmington

2010

Award for Innovative Excellence in Teaching, Learning, and Technology International Conference on College Teaching and Learning

2009

Discere Aude (Dare to Learn) Mentoring Award Center for Teaching Excellence University of North Carolina Wilmington

PROFESSIONAL ACTIVITIES

2009 - present

US Food and Drug Administration Drug Safety and Risk Management Advisory (DSaRM) Committee Center for Drug Evaluation and Research (CDER) Office of Surveillance and Epidemiology Consultant, Special Government Employee (2nd 5-year appointment)

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Susan M. Sinclair PhD, MPH, RN, FNAP

2009 ? present 2008 - present

Cymbalta Pregnancy Registry, Scientific Advisory Committee Lilly USA, LLC Indianapolis, Indiana Advisory Committee Member International Society for Pharmacoepidemiology (ISPE) Medications in Pregnancy Special Interest Group Bethesda, MD Member

2014 - present

University of North Carolina Wilmington Center for Health Communities Wilmington, NC Faculty Affiliate

2017

Center for Information & Study on Clinical Research Participation (CISCRP), Aware of All (event 15Nov17) Organization aims to educate and empower the public in making informed decisions about clinical research participation. Wilmington, NC Expert Panel Member

2015 - 2017

Brody School of Medicine, East Carolina University Office of Health Access Regional Community Health Needs Assessment (CHNA) Group Greenville, NC Member, Standardization and Uniformity Work Group

2014 - 2017

University of North Carolina Wilmington, Institutional Review Board Wilmington, NC Board Member ? Alternate

2011 - 2014

University of North Carolina Wilmington, Institutional Review Board Wilmington, NC Board Member

2013

Clinical Trials Transformation Initiative (CTTI) Pregnancy Testing in Clinical Trials Expert Meeting, July 15 - 16, 2013 Bethesda, MD Ex-officio Member of Expert Committee

2013

Interprofessional Education Collaborative (IPEC) Spring 2013 IPEC Institute 20-22 May 2013, Reston, VA Member of Faculty Delegation from UNCW

2009 ? 2011

International Society for Pharmacoepidemiology (ISPE) Bethesda, MD Co-chair of Academic Council

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