# 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/FSP-CRA--Shanghai-_266097?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_b604e2f2-f3f

## 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.

The successful candidate will be responsible for:

- Conducting site monitoring responsibilities for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits

- Preparing and implementing project plans related to Clinical Monitoring responsibilities

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

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

- Confirming Site Regulatory documents and eTMF/Sponsor Documents are complete and current

- Guaranteeing accurate Investigational Product inventory and accountability

- Ensuring adherence to global quality control and CRA performance metrics

- Ensuring audit readiness at site level

- Acting as a Lead CRA as assigned

The ideal candidate will have:

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

- Thorough understanding of ICH GCP Guidelines and local regulatory requirements

- Knowledge of monitoring procedures and basic understanding of the clinical trial process

- Fluent in local office language and English

- At least 2 years of Clinical Monitoring experience

Preferred qualifications include:

- 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

In return, you will receive a competitive salary and benefits package. You will also have the opportunity to work with a leading clinical trial services organisation and contribute to the development of new treatments and therapies.

**Physical Demands/Work Environment:**

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

- Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day

- 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

- Travel Requirement is 60% of the time (travelling to study sites)

## 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/FSP-CRA--Shanghai-_266097?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)