# Clinical Research Associate

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

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Hangzhou/FSP-CRA-I-II-S-Hangzhou-_266082?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ca3bf72b-437

## Description

We are seeking a Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for site monitoring and site management for clinical studies according to Company and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.

**Responsibilities:**

- Conduct routine monitoring and closeout of clinical sites, maintenance of study files, and pre-study and initiation visits

- Liaise with vendors and perform other duties as assigned

- Ensure study staff have received proper materials and instructions to safely enter patients into the study

- Verify informed consent procedures and protocol requirements are adhered to according to regulatory requirements

- Review source documents to ensure data integrity

- Monitor data for missing or implausible data

- Perform monitoring tasks efficiently and manage travel expenses according to Fortrea's travel policy

- Ensure audit readiness at the site level

- Travel may be required, including air travel

- Prepare accurate and timely trip reports

- Interact with internal work groups to evaluate needs, resources, and timelines

- Act as contact for clinical trial supplies and other suppliers

- Manage registry management as prescribed in project plans

- Undertake feasibility work when requested

- Participate in Quality Control Visits

- Recruit potential investigators, prepare EC submissions, and notify regulatory authorities

- Track and follow-up on Serious Adverse Event reporting

- Independently perform CRF review and query generation

- Assist with training and development of new employees

- Coordinate designated clinical projects as a Local Project Coordinator

**Qualifications:**

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

- Basic knowledge of Regulatory Guidelines and clinical trial process

- Fluent in local office language and English

**Experience:**

- 1 year experience in a clinical monitoring related role

- Basic understanding of Regulatory Guidelines

- Ability to work within a project team

- Good planning, organization, and problem-solving skills

- Good computer skills with good working knowledge of a range of computer packages

- Valid Driver's License

## Skills

### Required
- Regulatory Guidelines
- clinical trial process
- English

### Nice to have
- medical and clinical research terminology
- clinical research processes
- ICH GCP
- ISO 14155
- Microsoft Office applications
- CTMS

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Hangzhou/FSP-CRA-I-II-S-Hangzhou-_266082?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)