final

Rosa Gonzalez, CCRC

Miami, Florida ● (786) 477-9247 ● [email protected]

Clinical Research Coordinator

Work History

January 2018 – Present Clinical Research Coordinator

Miami Cancer Institute, Baptist Health South Florida

Miami, Florida

April 2011 – October 2017 Clinical Research Coordinator

Cardiovascular Research Center of South Florida

Medical Research Director: Jonathan Fialkow, MD

Miami, Florida

May 2005 – April 2011 Clinical Research Coordinator Neuroscience Consultants, LLC

Medical Research Director: Brad Herskowitz, MD

Miami, Florida

Experience

Oncology Research

· Lead Clinical Research Coordinator of Phase I, II, and III CNS, Breast, and Thoracic Tumor Sites

· Revised CRC Manual, Created Guidelines: RECIST/Ambra Request, AO Scheduling

· Collaborate on creating new workflkows

· Coordinate Care of new and established international patients traveling to MCI to participate in a CNS trial and continuing care overseas, including individualing shipping investigational product to their home

· Collaborate with Dr. Odia’s Invetogator Initiated Protocols and the COVID-19 Protocol Guidence Memo for 2017-ODI-001

Regulatory Affairs and Safety

· Conduct and complete trials in accordance with U.S. Food and Drug Administration (FDA), International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines.

· Provide support and timely follow-up for all audit and quality assurance activities.

· Submit and maintain study documents (i.e. 1572, Financial Disclosure Forms, Informed Consent Forms, Assents, HIPPA, etc.) in accordance with regulatory compliance.

· Prepare and process all documentation through the Institutional Review Board (IRB), including initial submissions, continuing reviews, amendments, protocol deviation, and adverse event reporting.

Study Development, Startup, and Closeout

· Facilitate Pre-Site Selection, Site Initiation, Interim, and Closeout visits.

· Conduct Phase III and IV clinical trials.

· Recruit, screen, and schedule subjects in adherence to the protocol requirements. Assist with confirmation of eligibility of potential study subjects for randomization.

· Complete all protocol specific procedures; perform ECGs; prepare, handle, and ship all required research lab specimens.

· Attend all Investigator Meetings, WebEx meetings, and all required trainings.

Documentation and Reporting

· Maintain all study documentation including source documentation, case report forms, and patient binders.

· Prepare and participate in audits conducted by sponsors and other oversight entities such as FDA and IRB.

· Complete all severe adverse event reports along with submission to sponsor or adjudication committee.

Training and Professional Development

· EQ-5D-5L Health Questionnaire by EuroQol Group

· Walking Impairment Questionnaire (WIQ)

· Pittsburgh Sleep Quality Index (PSQI)

· Dependence Scale (DS) Health Outcomes Rater Certification, i3 research

· Health Utilities Index (HUI) Health Outcomes Rater Certification, i3 research

· Quality of Life Alzheimer’s disease Scale (Qol-AD) Health Outcomes Rater Certification, i3 research

· Resource Utilization in Dementia (RUD) LITE 2.4 Health Outcomes Rater Certification, i3 research

· Quality of Life in Epilepsy Version 1.0 (QOLIE-31)

· Mini-Mental Status Examination (MMSE)

· Subject Global Impression of Change (SGIC)

· Columbia-Suicide Severity Rating Scale (C-SSRS)

· Montgomery-Asberg Depression Rating Scale (MADRS)

Education

August 2016 – Present Florida International University, Miami, Florida

Bachelor of Arts in Psychology

Estimate date of completion – January 2021

April 2016 Miami Dade College, Miami, Florida

Associates of Arts

Certifications

May 2008 – Present Certified Clinical Research Coordinator (CCRC)

Association of Clinical Research Professionals (ACRP)

https://proexamvault.com/badges/4d5e0e8d-d28f-483f-9c53-e122c0d4badc

April 2011 – Present GCP, ICH, Human Subject Protection, and HIPAA Certified

Collaborative Institutional Training Initiative (CITI)

June 2011 – Present Phlebotomy Technician Certification

June 2015 – Present Infectious Substance and Related Materials Certified (IATA)

Saf-T-Pak, Inc.

Professional Membership

2019 – Present Research Orders Committee

Co-Chair

2018 – Present Shared Governance Council

Council Member

List of all Clinical Trials, Sponsors, Contract Research Organizations (CRO), Laboratories, Institutional Review Boards (IRB), Electronic Case Report Form Software (eCFR)/Electronic Data Capture (EDC), Electrocardiogram Companies (ECG), and Interactive Voice Response Systems (IVRS/IWRS) experience available upon request.