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Clinical Research Manager

Location:
New York City, NY
Posted:
October 31, 2019

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Resume:

Michelle Gagnon Pritikin, MPH, ACRP-CP, CPH

*** ***** ****** ********* * New Rochelle, NY 10801 adap7i@r.postjobfree.com 201-***-**** EDUCATION Rutgers, The State University of New Jersey Piscataway, NJ Master of Public Health May 2014

Concentration: Epidemiology

Cumulative GPA: 3.77

Relevant Coursework: Regression Methods for Public Health, Health Care Policy, Applied Methods in Epidemiologic Research, Biocomputing (SAS), Outcomes Research, Comparative Effectiveness, Public Health in Developing Countries (Dominican Republic Outreach) The Pennsylvania State University University Park, PA Bachelor of Science, Health Policy and Administration May 2008 Bachelor of Science, Management

Minor in Human Development and Family Studies

Cumulative GPA: 3.52/4.00, Deans List: 2006-2008

Ireland Study Abroad Summer 2006 Program (Galway, Allihies, Dublin): Representing the Irish Landscape, Literature and the Visual Arts

PUBLIC HEALTH Mount Sinai Health System/ Icahn School of Medicine New York, NY EXPERIENCE Program Manager November 2017-present

Manage pediatric longitudinal clinical research studies focusing on early life predictors of chronic disease consisting of 1,700 study participants

Support a National Institutes of Health grant as part of a nationwide initiative to influence pediatric health outcomes

Develop a more efficient infrastructure to conduct sustainable large-scale recruitment, human specimen collection, and data management

Strategize for continuous, long-term growth of the study cohorts

Coordinate with hospital staff to ensure optimal and safe research operations

Implement and create quality improvement activities including policies and standard operating procedures

Oversee 15 direct reports’ daily activities while supporting a team of 30 employees

Responsible for human resource activities including hiring, evaluating, and discipline

Act as a coordinating site manager for two other data collection sites and one long-term sample storage facility

Program Coordinator II January 2016- October 2017

Provide administrative, operational and programmatic support services to longitudinal pediatric clinical research studies focusing on early life predictors of chronic diseases

Monitor 14 employees on the field team to ensure weekly completion of program activities

Implement a sample management system that merges with phenotypic data resulting in a comprehensive database

Act as a liaison between study and hospital staff in other departments to cultivate cooperative efforts to accomplish program objectives

Manage and organize the expansion of the field team by nearly 50%

Conduct new hire candidate interviews, orientation and paperwork

Complete all Institutional Review Board, regulatory applications, contracts, and renewals Memorial Sloan Kettering Cancer Center New York, NY Research Study Assistant / Study Coordinator February 2015- January 2016

Ensure sarcoma Phase I, II, and III clinical trials follow protocol guidelines

Coordinate 25 study visits and procedures per week for a diverse patient group

Assist clinical staff of 8 with study protocols and patient management in clinic

Maintain patient files and case report forms for adverse and serious adverse events

Perform data collection, entry, and analysis on sarcoma Phase I, II, and III studies

Collaborate with pharmaceutical sponsors to prepare for monitor visits

Manage the regulatory binder and submission of appropriate documents for monitors, IRB and FDA Rutgers Robert Wood Johnson Medical School New Brunswick, NJ Research Assistant May 2013-July 2014

Analyzed the association between an upcoming allocation scheme recommended by the Organ Procurement and Transplantation Network and overall mortality and graft failure, and explored its potential impact for older age groups using the United Network for Organ Sharing data on adult transplants

Created study protocol, statistical analysis plans, and an institutional review board application Research Piscataway, NJ

Master of Public Health Candidate May 2013-May 2014

Conducted research involving statistical analysis with large and national databases such as: o Performed a comparative effectiveness study involving Lyrica and Lidocaine dermal patches for reducing patient reported neuropathic pain

o Determined factors associated with body mass index levels among the nations’ pediatric population using the National Health and Nutrition Examination Survey o Studied association between adult vitamin D use and socioeconomic factors using the National Health Interview Survey

o Examined NJ and LA county differences for breast cancer treatments using the Surveillance Epidemiology and End Results database

Developed proficiency with SAS software to conduct various descriptive analysis and regression models including linear regression, logistic regression, and survival analysis using cox proportional hazards model

Interpreted and disseminated results of projects through report writing, delivering presentation to peers, faculty and clinical audiences

PROFESSIONAL Hays Specialist Recruitment, LLC Jersey City, NJ EXPERIENCE Executive Search Consultant, Clinical Research January 2012-May 2012

Provided exclusive and executive retained talent searches for pharmaceutical, biotechnology, and medical device clients

Effectively recruited mid to senior level executives within the Clinical Research field including Directors, Vice Presidents, and Managers

Developed a strategic plan to expand business within the Clinical Research market of Life Sciences

Coordinated interviews for quality candidates thereby ensuring the highest level of service for clients and candidates

Aerotek Staffing Piscataway, NJ

Recruiter (Professional Services) August 2010- December 2011

Searched daily for highly qualified individuals to meet our client’s expectations

Met tight deadlines in a highly competitive, fast paced environment

Assisted in developing 5 new client relationships to expand business development

Organized candidate interviews, new employee orientations, and new hire paperwork

Analyzed productivity to create innovative recruiting strategies to identify, maintain, and attract top talent on a weekly basis

Teach for America/Joseph J. Davies Elementary School Meraux, LA 2nd Grade Teacher/5th Grade Teacher August 2008- May 2010 Selected from approximately 19,000 applicants nationwide to serve in a highly acclaimed service corps

Completed The New Teacher Project, Practitioner Teacher Program; deemed a highly qualified teacher in Elementary Education (Grades 1-5)

Effectively supported students who were recovering from the effects of Hurricane Katrina

Utilized data-based decision-making and best practices which helped students achieve 1.4 years of growth by the end of the year

Enhanced the abilities of students who were performing below grade level to comprehend a variety of texts

Improved students’ writing techniques by 80% for students to compose a cohesive multi-paragraph essay PROFESSIONAL • Association of Clinical Research Professionals MEMBERSHIPS

PRESENTATIONS • Shah AP, Gagnon M, Chandwani S, Parikh A. Kidney Donor Profile Index: The Older You Are, The Harder it Gets. Poster Presentation at American Society of Nephrology Renal Week, Philadelphia, PA, November 11- 16, 2014.

COMPUTER SKILLS Statistical Analysis Software (SAS), Endnote, REDCap, Medidata, Labvantage, Microsoft Word, Excel, and PowerPoint



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