Summary
Overview
Work History
Education
Skills
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Languages
Personal Information
Timeline
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JACQUELINE RIZO GRANADILLO

Barranquilla,Colombia

Summary

Accomplished professional with extensive expertise in quality audits, corrective actions, and test plans. Demonstrates proficiency in software functionality, problem solving, and training. Adept at monitoring and auditing clinical trials, ensuring data collection, analysis, and study documentation meet stringent standards. Skilled in medical device management, quality control, infection control management, and epidemiology. Proven track record in clinical research management with a focus on protocol compliance and data accuracy. Strong leadership abilities complemented by teamwork, analytical skills, adaptability, flexibility, communication, and organisation. Committed to maintaining GCP and ICH-GCP guidelines while leveraging therapeutic area knowledge to enhance patient recruitment strategies and clinical study report writing.

Overview

16
16
years of professional experience
11
11
years of post-secondary education

Work History

Clinical Research Associate II

Thermo Fisher Scientific
Barranquilla, Colombia
08.2024 - Current
  • Implemented protocols, enhancing the efficiency of clinical studies.
  • Facilitated trial progression to meet project timelines efficiently.
  • Validated case report forms thus ensuring seamless data flow.
  • Managed trial documentation, ensuring high level of accuracy.
  • Maintained confidentiality of subject records, upholding ethical standards at all times.
  • Supported team members, promoting a collaborative working environment.
  • Assisted in compiling reports for presenting findings succinctly.
  • Reviewed trial data for identifying any irregularities swiftly.
  • Quickly learned and applied new skills to daily tasks, improving efficiency and productivity.
  • Successfully delivered on tasks within tight deadlines.
  • Cleaned work areas and equipment to maintain faultless hygiene standards.
  • Adhered to ICH-GCP guidelines throughout every phase of clinical trials.

Quality Assurance

Gaspy Home Healthcare
Barranquilla, Colombia
01.2023 - 11.2024

Demonstrated expertise in conducting quality audits and implementing effective corrective actions in
the different process that patients in home healthcare receive.

Proficient in developing and executing test plans to ensure software functionality • and performance.
• Communicating with other team members to solve problems
• Following up with the appropriate channels when mistakes are found
• Training other quality insurance members on all inspection processes

Clinical Research Associate Jr

VaxTrials
Barranquilla
04.2022 - 03.2023
  • In charge of carrying out management and supervision activities of the clinical study sites in accordance with ICH-GCP (Good Clinical Practices) the sponsor's SOPs (Standard Operator Procedures) according to the different local regulations, conduct follow-up monitoring visits of the protocol, site supervision plan and associated documents.
  • STUDIES: IVI-CHIK-001 Phase II/III (Chikunguña- 2 sites -IMV), CLO-SCB-2019-003 Phase II/III (Covid19 -2sites-DBL), NOR-212 Phase II/III (Norovirus- 1 site- SIV)
  • Achievements: Together with my work team, I guaranteed the successful completion of a COVID-19 vaccine study protocol, which helped guarantee the safety and health of patients.
  • Develop social and communication skills during the monitoring visits that allowed establishing trustworthy networks with the research sites that favored the proper development of the clinical protocols and the commitment of all the study staff.
  • I implemented administrative tools that allowed to leave with greater organization and traceability the development of the different processes of the position in conjunction with the CTA (Clinical Trial Assistant)

Clinical Application Specialist

Biomerieux Colombia SAS
Barranquilla
09.2014 - 03.2023
  • Improvements and speed were achieved in the implementation of the different clinical laboratory procedures, resulting in a fast and timely diagnosis.
  • I was able to support the sales staff, achieving satisfaction with the company's KPIs and exceeding the percentage of estimated sales during the pandemic.
  • Value-added courses were given to the institutions, guaranteeing the satisfaction of current and potential clients.
  • I supported the participation of the bioMérieux brand in congresses and clinical forums, positioning the company in the country.

Clinical Study Coordinator

Biomelab
Barranquilla
07.2012 - 08.2014
  • STUDIES: Diabetes -Phase III- Rewind- Elly Lilly and Company, Osteoporosis- Phase III-MK 822-018- MSD, Osteoporosis-Phase II- AMG337-AMGEN
  • Achievements: In support of the study staff, it was possible to write scientific reports on the conclusions on the efficacy and safety of the drugs; the results were presented in magazines and congresses of the sponsor.
  • I managed to carry out the successful completion of different study protocols through strategies, approaches and development of clinical activities for the approval of a new drug favoring the improvement of public health.

Associate Data Coordinator

MSD
Bogota
09.2009 - 07.2012
  • Achievements: I was able to obtain high quality information which allowed the sponsor to accurately develop data analysis, establish conclusions that allowed the final development of the study protocol.
  • I identified the errors in the quality of the data that put at risk the obtaining of the information and the handling of the integrity of the data.

Education

MSc - Microbiology

Universidad Metropolitana
Barranquilla, Atlántico
01.2016 - 01.2021

Bachelor of Science - MLT

Universidad Libre de Colombia
Barranquilla, Atlántico
01.1999 - 01.2005

Skills

  • Quality Audits
  • Corrective Actions
  • Test Plans
  • Software Functionality
  • Problem Solving
  • Training
  • Monitoring
  • Auditing
  • Clinical Trials
  • Data Collection
  • Data Analysis
  • Study Documentation
  • Medical Device Management
  • Quality Control
  • Infection Control Management
  • Epidemiology
  • Statistics
  • Clinical Research Management
  • Document Organization
  • Protocol Compliance
  • Data Accuracy
  • Participant Recruitment
  • Coding of Medical Terms
  • Data Management
  • Information Review
  • Leadership
  • Teamwork
  • Analytical Skills
  • Adaptability
  • Flexibility
  • Communication
  • Organization
  • GCP
  • ICH-GCP
  • Therapeutic area knowledge
  • Patient recruitment strategies
  • Clinical study report writing
  • Understanding of ich guidelines

Languages

Spanish
English

Personal Information

Nationality: Colombian

Timeline

Clinical Research Associate II

Thermo Fisher Scientific
08.2024 - Current

Quality Assurance

Gaspy Home Healthcare
01.2023 - 11.2024

Clinical Research Associate Jr

VaxTrials
04.2022 - 03.2023

MSc - Microbiology

Universidad Metropolitana
01.2016 - 01.2021

Clinical Application Specialist

Biomerieux Colombia SAS
09.2014 - 03.2023

Clinical Study Coordinator

Biomelab
07.2012 - 08.2014

Associate Data Coordinator

MSD
09.2009 - 07.2012

Bachelor of Science - MLT

Universidad Libre de Colombia
01.1999 - 01.2005
JACQUELINE RIZO GRANADILLO