# Senior CRA I

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

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Shanghai/Sr-Clinical-Research-Associate-I_265004?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ad3b90e7-479

## Description

The Senior CRA I is responsible for site monitoring and site management, ensuring clinical studies are conducted according to Fortrea and Sponsor Standard Operating Procedures, and Regulatory Guidelines.

Responsibilities:

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

- Manage site management as prescribed in project plans.

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

- Verify informed consent procedures and protocol requirements are adhered to.

- Review source documents to ensure data integrity.

- Monitor data for missing or implausible entries.

- Perform monitoring tasks efficiently, managing travel expenses according to Fortrea's travel policy.

- Prepare accurate and timely trip reports.

- Manage small projects under a Project Manager/Director's direction.

- Serve as lead monitor for a protocol or project.

- Participate in protocol development and clinical trial report writing.

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

- Coordinate clinical projects as a Local Project Coordinator.

Qualifications:

- University or college degree in life sciences or a related field, or certification in a related allied health profession.

- Three years of clinical monitoring experience.

- Thorough knowledge of regulatory requirements and the drug development process.

- Fluent in local office language and English.

- Advanced site monitoring, study site management, and registry administration skills.

- Ability to work with minimal supervision and train junior staff.

Preferred Qualifications:

- Additional experience in a related field.

- Local project coordination or project management experience.

Physical Demands/Work Environment:

- Travel requirements: 60-80% overnight.

## Skills

### Required
- clinical research
- site monitoring
- regulatory guidelines
- study management
- data analysis
- communication

### Nice to have
- local project coordination
- project management

---

Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Shanghai/Sr-Clinical-Research-Associate-I_265004?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)