# Clinical Research Associate

**Company**: Fortrea
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Guangzhou/FSP-CRA-Guangzhou-and-Southern-cities-_251953?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_58f0655f-1d5

## Description

Fortrea is seeking a Clinical Research Associate to manage clinical studies according to their Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.

Responsibilities:

- Manage clinical studies, including site management and monitoring responsibilities

- Conduct site monitoring visits, including pre-study, initiation, process monitoring, routine monitoring, and close-out visits

- Prepare and implement project plans related to Clinical Monitoring responsibilities

- Ensure subject protection by verifying informed consent procedures and protocol requirements

- Safeguard data integrity through source document review and verification

- Confirm site regulatory documents and eTMF/Sponsor documents are complete and current

- Ensure adherence to global quality control and CRA performance metrics

- Travel to study sites, which may be required up to 60% of the time

Qualifications:

- University or college degree in a related allied health profession (e.g., nursing licensure)

- Thorough understanding of ICH GCP Guidelines and local regulatory requirements

- Basic understanding of the clinical trial process

- Fluent in local office language and English, both written and verbal

- Minimum 2 years of Clinical Monitoring experience

Preferred Qualifications:

- Thorough working knowledge of Fortrea SOPs for site monitoring

- Additional years of experience in a related field (e.g., medical, clinical, pharmaceutical)

- Phase I monitoring experience

- Life Science or Nursing qualification

- Good attention to detail and methodical approach to work

Physical Demands/Work Environment:

- Must be able to sit at a computer for long periods

- Must be able to use hands to finger, handle or touch objects, tools or controls

- Standard office and/or home working environment

- Clinical Research Unit and hospital environment (administrative only)

- Risk of eye strain

- Will involve outside of normal office hours as required by the role

## Skills

### Required
- ICH GCP Guidelines
- Clinical Monitoring
- Source Document Review
- Data Integrity
- Regulatory Requirements

### Nice to have
- Fortrea SOPs
- Phase I monitoring
- Life Science or Nursing qualification
- e-clinical systems

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Guangzhou/FSP-CRA-Guangzhou-and-Southern-cities-_251953?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)
