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Juan Alberto Arango Muñoz
Clinical Research Associate II
Summary
Competent Clinical Research Associate skilled at conducting site visits to check clinical operations and correct participant, documentation, or procedure issues. Highly experienced within Vaccines, Respiratory, Endocrinology and Cardiovascular Clinical Trials to evaluate medical, surgical and behavioral interventions. Excellent attention to detail with organizational and prioritization skills for efficient productivity.
Overview
4
4
years of professional experience
2
2
Languages
Work History
Clinical Research Associate II
Novo Nordisk México, S.A. de C. V
01.2024 - Current
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Ensure adequate monitoring process by using Risk Based Monitoring and following the study-specific monitoring plan for SDV and SDR of critical data points and processes
- Conduct Site Selection, Initiation, monitoring and close out visits, according to the protocol, SOPs, Local Regulation, ICH GCP international guidelines
- Ensure that relevant documents are submitted and approved by the EC and HA (with Regulatory team support)
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Plan with the Clinical Research Sites Recruitment and ensure the adherence and achievement of weekly/monthly targets
- Work with the sites to ensure patient retention by promoting and supporting the sites to perform relevant retention strategies
- Knowledge of quality KPIs and ensure adherence
- Prompt resolution and escalation of issues/deviations that may affect quality: Data Integrity, Scientific Validity, and patients' well-being and safety
- Identifies and mitigates risks and avoids incidences by conducting effective RCA and CAPA
- Together with the TM takes owner role during audits or inspections
- Works with simplicity by eliminating unnecessary complexity and continuous work improvement
- Full understanding of international and local regulations on Clinical Trials
Clinical Research Associate I
ICON Clinical Research México
07.2022 - 01.2024
- Track subject enrollment and identify R&R issues, maintain regular communication w/site staff
- Document and communicate study site progress and issues/concerns to the project team
- Offer resolution strategies, documenting follow-up activities/outcomes, collection efforts, meetings, present or set up task force, as directed by the client CPLs
- Schedule and prioritize workload to meet projected deadlines
- Provide adequate reporting and tracking of AEs, protocol deviations and subject status
- Conduct all work according to client SOPs: Potential Investigator Selection, Study Initiation, Monitoring and Closeout Visits
- Manage and maintain TMF updated, as appropriate, including reference study/site files to support monitoring responsibilities
- Reconciliation and generation of the Investigator payments for the study procedures
- Regulatory start-up activities and dossier elaboration for MoH submission
Clinical Research Associate I
EPIC CRO S. de R. L de C. V.
11.2021 - 07.2022
- Project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical studies in accordance with sponsor SOPs, ICH-GCP, Clinical Practice Standard and other applicable regulations
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Ensuring that all data generated by the assigned sites is of high quality, on time and within budget
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
Medical Research Assistant Trainee
Unidad de Medicina Experimental del Hospital General de México
09.2020 - 02.2021
- Design of study protocol to evaluate the anti-inflammatory properties of Silymarin in Alzheimer models
- Training in molecular biology techniques
- Scientific dissemination regarding neurodegenerative diseases and addictions
Education
Bachelor of Science - Biopharmaceutical Chemistry
National Autonomous University of Mexico
Mexico City, Mexico02-2021
Skills
Clinical data management
Clinical documentation
Quality control
IRB submissions
Site management
Site monitoring
Clinical trial management
Coordinating site operations
Patient recruitment strategies
Good clinical practices
Trial oversight
Teamwork
Accomplishments
- Awarded as CRA Frontliner in Novo Nordisk for Highly Successful Performance in Q2 2024.
- Achieved 100% patient retention in High Recruiter Study (over 400 patients in Mexico) through effectively helping assigned sites with retention activities and identification of potential Lost to Follow Up patients.
- Highly Successful Performance rate for annual evaluation 2023 in ICON Plc.
Software
Electronic Data Capture (EDC) Systems
IWRS
ECOA
CTMS
Timeline
Clinical Research Associate II
Novo Nordisk México, S.A. de C. V
01.2024 - Current
Clinical Research Associate I
ICON Clinical Research México
07.2022 - 01.2024
Clinical Research Associate I
EPIC CRO S. de R. L de C. V.
11.2021 - 07.2022
Medical Research Assistant Trainee
Unidad de Medicina Experimental del Hospital General de México
09.2020 - 02.2021
Bachelor of Science - Biopharmaceutical Chemistry
National Autonomous University of Mexico
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