# Senior Clinical Research Associate I

**Company**: Pfizer
**Location**: São Paulo, Brazil
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Brazil---So-Paulo/Analista-de-Pesquisa-Clnica-Sr_4961640?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_e1d79813-535

## Description

The Senior Clinical Research Associate I is responsible for site management, site monitoring, and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution.

Responsibilities:

- Manage investigator site relationships to ensure effective delivery of clinical trials.

- Monitor site level adverse events and serious adverse events.

- Conduct onsite, remote, or electronic monitoring as needed for study site initiation, routine monitoring, and study site closure activities.

- Submit all required reports, documentation, updates, and tracking within required timeframes.

- Identify and resolve investigator site issues within required timeframes.

- Resolve data queries within required timelines.

- Ensure adequate oversight of the investigational product at the investigator site.

Qualifications:

- Medical background or equivalent.

- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations.

- Minimum 3 years relevant experience in clinical research site monitoring.

- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

- Global clinical trial experience.

- Fluency in English and the native language(s) of the country.

Physical/Mental Requirements:

- Advanced knowledge of clinical research and development processes.

- Demonstrated knowledge of global and local regulatory requirements.

- Advanced understanding of key operational elements of clinical research.

- Proven ability to work in a matrix team environment.

Non-Standard Work Schedule, Travel, or Environment Requirements:

- Significant travel (60-80%) within the area is required.

- Valid passport required.

Organizational Relationships:

- Partners with Site Care Partner and Country SOM.

- Reports to Director of Clinical Site Operations, or Director of Site Management and Monitoring, or Site Care Partner III.

## Skills

### Required
- clinical trial methodologies
- ICH/GCP
- FDA regulations
- local country regulations
- Oncology
- Vaccines
- Internal Medicine
- Infectious Diseases

### Nice to have
- therapeutic experience in Oncology

---

Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Brazil---So-Paulo/Analista-de-Pesquisa-Clnica-Sr_4961640?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)