Ma. Anita Gonzales

Sennior Clinical Research Associate

ICON Strategic Solutions

May 2024 - Current (2 years 6 months)

Assigned to Astrazeneca

Sr. CRA I

Syneos Health

Aug 2021 - May 2024 (2 years 10 months)

Clinical Research Associate II

IQVIA

Mar 2021 - Aug 2021 (6 months)

Clinical Research Associate II

Ascent Development Services

Apr 2019 - Mar 2021 (2 years)

I

Clinical Research Associate

Integrated Development Associates Co Ltd

Oct 2017 - Mar 2019 (1 year 6 months)

Medical Affairs Associate

Novartis

Jan 2017 - Oct 2017 (10 months)

- Work with Medical Experts and accrediting bodies to evaluate medical education needs and develop accredited and non-accredited educational programs.
- Recognized valued partner for the development of medical education initiatives which improve health care professionals’ knowledge and patient outcomes.
- Support the content development, facilitation and execution of Medical/Mixed Advisory Boards and Consult Meetings.
- Lead the development of medical education initiatives through solid needs analysis by working with medical experts and accrediting bodies.
- Ensure continuous communication with colleagues from commercial and medical to validate and ensure optimal and compliant implementation of key educational initiative

Multiple Patient Program Monitor

Novartis

Jul 2016 - Dec 2016 (6 months)

- Assumed ambassadorial role to facilitate communication between sites and Novartis CPO to ensure proper program implementation
- Prepared and collected site-level documents during all phases of the program and resolved problems as required
- Collected adverse event reports from treating physicians and reported to concerned units in Novartis for processing and reporting to FDA.
- Ensured proper maintenance of Patient Specific Folders
- Facilitated FDA submission of Compassionate Special Permit compliance in collaboration with the site physician
- Implemented total site management including site visits, regulatory assessment, and drug supply management
- Assured continual FDA and Novartis SOP compliance

Clinical Research Assistant (Intern)

Wyeth Philippines Inc

Jul 2015 - Sep 2015 (3 months)

- Review and manage data obtained from clinical research trials (i.e. Case Report Forms)
- Handle documents needed for regulatory approval (i.e. FDA and IRB Submissions)
- Review relevant documents of the study such as Source Documents and Investigator's Brochure
- Update database for Case Report Forms and information in Electronic Data Capture System
- Exposure and adherence to Good Clinical Practice Guidelines

G

Manufacturing Pharmacy Intern

Growrich Manufacturing Inc

May 2014 - Jun 2014 (2 months)

- Formulation of protocols for basic manufacturing and quality control operations
- Conduct laboratory tests for quality control analysis of raw materials
- Perform in-process and final product quality control checking
- Exposure to basic administrative operations of the company

Hospital Pharmacy Intern

Philippine General Hospital

Apr 2013 - May 2013 (2 months)

- Dispense medication to patients in adherence to hospital guidelines and laws on generic prescribing
- Participate in patient rounds to ensure proper medication use
- Practice patient counseling on drugs and devices to ensure rational drug use

Community Pharmacy Intern

Generika Drugstore

Apr 2012 - May 2012 (2 months)

Ma. Anita Gonzales

About

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Résumé

Ma. Anita Gonzales

About

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Behavioral traits