# 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/Shanghai/CRAII_265297?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_b900a172-4b8

## Description

We are seeking a Clinical Research Associate to manage clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.

**Job Summary** As a Clinical Research Associate, you will be responsible for site management and monitoring of clinical trials. This includes verifying study training records, conducting site initiation visits, routine monitoring, and close-out visits. You will ensure the protection of subjects, safeguard data integrity, and confirm site regulatory documents are complete and current.

**Responsibilities**

- Manage clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements

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

- Prepare and implement project plans related to Clinical Monitoring responsibilities

- Ensure the protection of subjects by verifying informed consent procedures and protocol requirements are adhered to

- Safeguard data integrity through source document review, source document verification, query generation, and resolution

- 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 include air travel, and prepare accurate and timely trip reports

- Independently perform eCRF review, source data verification, query generation, and resolution

- Assist with administration of clinical research projects, recruiting investigators, collecting investigator documentation, and site management

- Update and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems

**Qualifications**

- University or college degree, or certification in a related allied health profession

- Thorough understanding of ICH GCP Guidelines and local regulatory requirements

- Thorough knowledge of monitoring procedures

- Basic understanding of the clinical trial process

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

- A minimum of 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

- Phase I monitoring experience

- Life Science or Nursing qualification

- Specific skills, systems, certifications, and/or licenses

- Good attention to detail, methodical approach to work, and good understanding of medical and clinical research terminology

**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

- Risk of eye strain

- Will involve outside of normal office hours as required

- Travel Requirement is 60% of the time

## Skills

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

### 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/Shanghai/CRAII_265297?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)