Clinical Research Associate

MO N S E . B A E Z A @G MA I L . C O M

(* * * )* 8 4 - 2150

MO NSERRAT BA E Z A

EDUCATION

San Jose State University San Jose, CA

**** – 2016 • Bachelor of Science in Forensic Science, Molecular and Cellular Biology

• Minor in Chemistry

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PROFESSIONAL EXPERIENCE

Luminist, Inc.

Oct 2017-Present Clinical Research Associate Newark, CA

• Maintains study activity with internal clinical trail management system and eTMF to meet ICH/GCP requirements.

• Responsible for writing basic protocols, monitoring clinical sites to ensure protocol adherence, assuring timely enrollment of patients, and retrieval of CRFs from study sites.

• Manages over 30 clinical trail site performances by tracking regulatory submissions, recruitment, CRF completion, and EDC query resolution.

• Reviews study documents including: protocols, consent documents, inclusion/exclusion criteria, regulatory packets and IRB submissions, adverse event monitoring plans, and SOPs.

• Executes site initiation, study visits, and study close-out activities.

• Handle and processes biological samples (recording, aliquoting and storage of specimens) from trial sites, conduct lab kits and lab maintenance activities such as instrument maintenance/troubleshooting, and lab organization. United Health Foundation

Scholar Clinical Intern San Jose, CA

Aug 2014-Dec 2016 • Researched grant and funding opportunities for clinics serving the underserved population in the surrounding Bay Area.

• Shadowing patient visits.

• Assisted with all administrative duties including greeting, filing, scanning, sorting mail, and patient calls.

HealthPoint

Communications Research Assistant

San Jose, CA

Sept 2013 – Feb

2014

• Conducted baseline interviews and questioners that tested the effectiveness of HPV Vaccine education.

• Developed flexible recruitment protocol for enrolling participants, recruited study participants via phone interview.

• Ensured proper data entry in electronic database. SKILLS AND TRAINING

• Proficiency in Microsoft Word,

PowerPoint and Excel

• Knowledge of IRB policies and

procedures

• Working knowledge and in compliance

with applicable ICH-GCP Guidelines

• General Laboratory techniques

• CITI Good Clinical Practice certified, 2017

• CITI Shipping and Transport of Regulated Biological Materials certified, 2017

• Biosafety and Bloodborne Pathogens certified, 2017

• HIPPA/PHI confidentiality trained

• American Heart Association - CPR certified, 2015

• Bi-lingual (English and Spanish)

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