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Clinical Research Maintenance

Huntington, New York, United States
October 24, 2016

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Clinical Compliance Oversight Clinical Research

Regulatory Reporting Record Maintenance Technology

Assessment Subject Screening

Seasoned, reliable clinical Research Coordinator and Research Associate with a strong compliance oversight and regulatory focus balanced with personal warmth and interpersonal skills.

Experience practicing, teaching, and researching within the pharmaceutical and healthcare industries.

In-depth knowledge of GCP and ICH guidelines, therapeutic and protocol competencies; ability to design study tools and follow studies through to successful completion.

Flexible and adaptable in fast-changing scenarios; able to travel extensively.

Long-time interest in both time management and handling competing priorities. Well-organized and self-directed. Able to lead by example.

Strong technology skills, including Excel and Word, Observer XT software, Electronic Data Capture (EDC), RAVE-Medidata, Novo Nordisk Interactive Voice Response (IVR), Novo Nordisk Global Haemophilia Network, Novo Nordisk Clinphone, TEMPO- (EDC)

Proven history of exceeding goals, building strong, collaborative relationships and positively contributing to a high-performance clinical environment.


NORTH SHORE-LIJ HEALTH SYSTEM, Division of Allergy/Immunology

Lead Research Coordinator September 2015–June 2016

Coordinated the daily activities and analysis of a wide range of clinical studies.

Monitored high-profile research trials; actively oversaw recruitment of study participants.

Adhered to GCP regulatory and grant agency requirements, as well as study protocols.

Maintained detailed study records and collaborated with colleagues, department heads and the Board.

Key Studies

Evaluation of Hypoallergenicity of a new extensively hydrolyzed formula. Protocol # 12.24 CLI. Sponsor: Nestle. Initiation and maintenance phase. Phase 3.Allergy.

The Gut Microbiome in the Food Allergic Host Protocol #14- 249A.Sponsor: Department of Allergy & Immunology, NorthShore-LIJ. Maintenance phase. Phase 1. Allergy.

The role of glucocorticoid receptor B in steroid insensitivity among obese atopic asthmatics, Protocol # Sponsor: American College of Asthma, Allergy and Immunology. Maintenance phase. Phase 3. Immunology.


Lead Research Coordinator March 2015-September 2015

Coordinated and managed clinical research studies as directed by Principal Investigator.

Educated clients and families, either one-on-one or in group sessions, explaining purpose and possible effects of clinical trial; promoted safe and accurate adherence to research protocols of the clinical trials; monitored clients' health to detect and prevent adverse reactions to medication; followed up by telephone as required.

Participated in data collection related to clinical trials; entered research data into case report forms and/or databases as mandated by research protocols.

Acted as a liaison between research study sponsors and department staff, ensuring that all reporting deadlines were met.

Recruited, screened, provided consent information to and scheduled subjects.

Maintained records and documents as mandated by clinical research sponsors in

accordance with research regulatory guidelines.

Key Studies

A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients with Inflammatory Bowel Disease. Maintenance phase. Phase 3. Pediatrics

Executive Function In Children With Hypertension (Observational Study). Maintenance phase. Phase 3. Hypertention.

Paradigm 5, Safety, Efficacy and Pharmacokinetics of NNC-015*-****-**** in Previously Treated Children with Haemophilia B. Co-Investigator, NovoNordisk, NN7999-3774. Maintenance phase. Phase4 and closeout.


Special Project Consultant “How to Reduce Turnaround Time in the IRB” 2014


Research Coordinator/Patient Safety Center for Learning & Innovation (CLI) 2013 to 2015

“Correlation of the Predictive Ability of Early Warning Metrics and Mortality For Cardiac Arrest Patients Receiving in-Hospital Advanced Cardiovascular Life Support. Initiation, maintenance, and closeout phase.

Coordinate the daily activities of the designated study or group of studies and monitor research trial. Adhere to Good Clinical Practice, and comply with regulatory and grant agency requirements. Study protocol and maintain study records and collaborate with the Institutional Review Board as necessary. Responsible for data-mining operation to create a complete and accurate computer database of all research subjects. Phase1. Educational Research.


Clinical Instructor


Dr. Steven P. Engebretson, DMD, MS, MS, is an expert in the area of diabetes and oral health. In 2008 he received a $12.5 M grant from the NIH in 2008 for a major diabetes and periodontics clinical trial: The Diabetes and Periodontal Therapy Trial (DPTT). The study completed in 2012. He is also the principal investigator on three supplemental awards for the DPTT totaling more than $2.5 M.

Clinical Research Associate

Support research and operations for Dr. Steven P. Engebretson, DMD, MS, MS, Conducted day-to-day execution of clinical research protocol including obtaining informed consent, completing study procedures, and dispensing, accounting for study drug, and documenting drug compliance.

Responsible for recruiting prospective research subjects for clinical trial. Responsible for clinical tasks including non-surgical periodontal therapy for all Treatment Group participants during the follow-up period, and for the Control Group participants at their 6-month visits. In addition to clinically screening subjects for clinical eligibility and conducting telephone interviews to determine subject eligibility.

Spearheaded recruitment efforts. Responsible for recruitment entry database of recruitment subjects. Worked within departments in extensive data-mining operation to create a complete and accurate computer database of all extant research subjects. Developed brochures and other materials approved for use by local IRB (CORIHS) in collaboration with other clinical site personnel. Educated eligible, interested patients on the details of the study. Scheduled screening appointments for potential subjects. Followed up with eligible subjects after the screening visit and scheduled baseline visits at the dental clinic. Maintained recruitment records, and worked closely with the clinical site study coordinator diabetes clinic staff, and dental clinical staff to help remind patients of their appointments and to enhance retention efforts. Assisted in site monitoring visits to provide access to study document. Participate in meetings with sponsors, monitors and regulatory authorities, as necessary.

Managed all points in the process of recruitment: Worked closely with departmental heads in Cardiology, Endocrinology, Internal Medicine, Primary Care, Dental Department, IT Department Acted as the chief liaison to the advertising department, and assisted in the development of various media for community outreach. Assisted in the design of a web site.

Key Highlights

Exceeded recruitment goal by 100% through effective community outreach

Ensured studies were conducted according to the investigator statement agreement, protocol and regulatory requirements.

Key Studies

Principal Investigator Periodontal Disease and Type 2 Diabetes: A Pilot Study of Physician Assistants Knowledge, Practices, and Referrals. IRB ID: 2012-10-01. Phase 1.

National Institute of Dental and Craniofacial Research, 3 UO1 DE 018902-04S1, Diabetes and Periodontal Therapy Trial (DPTT) Supplement, Clinical Site Stony Brook, 100% effort

The Effect of Simulation Training on the Quality of Patient Cardiopulmonary Resuscitation Outcomes, 100% effort. Phase 3 and closeout. Diabetes.


“Adding Fluoride Varnish to Your Armamentarium,” Dental Tribune, August, 2009

“Oral Manifestations and Management of Cancer Patients,” Dentistry IQ, May, 2010

“Correlation of the Predictive Ability of Early Warning Metrics and Mortality For Cardiac Arrest Patients Receiving in-Hospital Advanced Cardiovascular Life Support” has been accepted for publication in Heart & Lung.


Master of Science in Dental Hygiene

University of Bridgeport

Bachelor of Science in Dental Hygiene

Farmingdale State College

Associate of Science in Dental Hygiene

Hudson Valley Community College

Applied Leadership, Effectiveness And Development Program (ALEAD)

Certificate of Completion

Certification in Protecting Human Research Participants (NIH)

Certificate in Human Research Curriculum CITI Collaborative Institutional

Certificate in HIPAA Research Training

Laboratory Safety–Biological Hazards

Laboratory Safety–Shipping of Dangerous Goods

Laboratory Safety–Blood Borne Pathogen Training

Laboratory Safety–Regulated Medical Waste Management

Environmental Awareness–Hazards Waste Management


Didactic Student Teacher, School of Dental Medicine, Stony Brook, New York

Clinical Student Teacher, Farmingdale State College, Farmingdale, New York


ACRP, Academy of Clinical Research Professionals AADH, Governing Committee, Finance Chairperson, Membership Committee, Treasurer ADHA

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