Hailey Goldberg

Home: (416-785-5679) Cell: (416-616-0091)

E-mail: [email protected]

PROFILE
Highly motivated and hardworking Masters graduate with proven success in managing and the development of clinical research projects including phase I to III clinical trials. Developed IWRS modules for multiple studies in collaboration with multiple teams including project management, software management, and quality assurance and demonstrates consistent ability to perform efficiently in a group setting. Offers attention to detail and ensures accuracy and timely delivery on all task. Knowledgeable with industry regulations (ICH, GLP, GCP, FDA and Health Canada guidelines) and EDC systems. Proficiency in scientific writing and extensive scientific background. Therapeutic areas include:

• Inmmunology              • Oral Immunology         • Oncology

• Bone Metabolism        •Dermatology                • Pain Management

• Endocrinology                        • Virology                     • Neurology

Respirology

Key Competencies Include:

·         Development of Randomization and Drug Tracking Modules

·         Clinical research and drug development

·         Customer focused attitude with years of customer service experience

PROFESSIONAL EXPERIENCE
Everest Clinical Research Corporation, Markham, Ontario               September 2016 – Present

Clinical Trials IWRS Monitor II

·         Act as primary contact with IWRS Users for the Everest IWRS team via the IWRS Helpdesk telephone or IWRS email accounts.

·         Support communications and coordination with Sponsors, Study Team Members, Depot personnel and internal Everest data management and statistical leads across the IWRS development lifecycle.

·         Conduct IWRS demonstrations to sponsors as well as training demonstrations to study team members.

·         Support client request and issue analysis, problem solving and resolution, working closely with IWRS Developers, internal Everest Data Management and Statistical and Programming teams.

·         Monitor data generated within IWRS to ensure accuracy and quality.

·         Coordinate and verify changes to the database and application using appropriate change control procedures and ensuring comprehensive and accurate documentation is completed.

·         Act as off-hours escalation point for junior IWRS Clinical Monitor resources or the outsourced call center service to resolve high urgency client requests (based on agreed rotational schedule amongst IWRS Clinical Trials Monitor resources).

·         Generate, maintain and/or review IWRS Requirements Specification documents.

·         Execute IWRS application test planning, test plan and test script development and Stage I and II testing activities for IWRS applications (newly developed applications or application change requests). These tasks are performed in a systematic and very detailed manner using the IWRS Requirements Specification document as the base for testing IWRS functionality.

·         Generate, maintain and/or review Quick Reference Guides for all IWRS studies.

·         Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on IWRS applications.

Axiom real time metrics, Toronto, Ontario

Project Management Associate                                                            April 2015-July 2016

·         Ensured that studies adhered to regulatory guidelines

·         Project management of clinical trial start-up, maintenance and study close out

·         Performed daily management of Randomization and / or Drug Tracking Module activity for multiple clinical trials and registry projects

·         Collaborated closely with interdisciplinary team members of the Data Management, Quality Assurance Team, Product Management Team and Sponsor Team.

·         Responsible for management of the randomization schedules, drug tracking schedules, maintenance of randomization and IP lists

o    Day-to-day management of projects and ensuring responsive, timely communication with our clients and sites

o    Implemented and tested forms and reports within Axiom’s software suite

o    Data entry and review

·         Module Configuration – created and managed randomization lists and IP lists within the EDC system.

·         Performed tasks related to EDC configuration, eCRF design and task management

Rebate 4U, Toronto, Ontario

Rebate Specialist                                                                                                               2014-2015

·         Informed clients on the HST new housing rebate program

·         Completed rebate applications for clients

·         Represented clients with the CRA

Track Fitness, Toronto, Ontario

Fitness Instructor, Reception                                                                                           2013-2014

·         Greeted clients and signed them into their classes

·         As a Certified fitness instructor, taught fitness classes

·         Gym schedule management

University of Toronto, Toronto, Ontario

Research Assistant to Dr. Michael Glogauer                                                                          2010

·         Performed lab and clinical work investigating the role of Neutrophils in patients with periodontitis

·         CIHR group in Matrix Dynamics

·         Developed an assay to visualize neutrophil extracellular traps by neutrophils

Western University, London, Ontario

Research Assistant                                                                                                                    2009

·         Assisted masters and PhD students with their research in plant genetics

·         Researched trichromes developing in different types of plants with altered genes

Georgian Peaks Ski Club, Collingwood, Ontario

Ski Coach                                                                                                                           2004-2006

·         Level 1 Ski Coach Certification from Canadian Federation of Ski Coaches

·         Prepared lesson plans

·         Coached children 11-12 years old in Ski Racing Program

EDUCATION
Faculty of Dentistry, University of Toronto, Toronto, ON

Masters, Science (Immunology)                                                                                      2011-2013

·         Focus of Research: Immunology, polarization of macrophages in patients with periodontitis.

·         Graduate Student’s Union representative for the faculty of Dentistry

University of Western Ontario, London, ON                                                                    Bachelor of Science, Honours Biology                                                                          2007- 2011

·         Honors Specialization in Biology

·         Dean’s List: 2009-2011

CERTIFICATIONS & AWARDS
·         GCP for Clinical Trials with Investigational Drugs & Biologics, CITI at University of Miami, 2015

·         Academic fellowship from the Faculty of Dentistry, 2012

·         University of Western Ontario Dean’s List: 2009-2011

PUBLICATIONS & PRESENTATIONS
·         Rac2 is required for formation of extracellular traps by neutrophils. Published in the Journal of Leukocyte Biology. 2011. Secondary author.

·         Matrix dynamics group seminar oral presentation. October 29, 2012. Primary author

·         Oral health seminars oral presentation. November 6, 2012. Primary author

VOLUNTEER WORK
·         Track 3 Ski Association, 2008-2010

·         Magen David Adom, 2008

INTERESTS AND LANGUAGES
·         Fluent in English and Hebrew

·         Skiing

·         Extreme Sports Competitions

·         Marathon running

·         Sailing

·         Cooking