# 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/Beijing/FSP-SCRA-I--Beijing-_266101?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_7d037ace-e49

## 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.

The Senior CRA I will implement project plans, lead projects of limited scope, and assume line management responsibilities as assigned.

Key responsibilities include:

- Conducting site monitoring, including routine monitoring and closeout of clinical sites

- Maintaining study files and conducting pre-study and initiation visits

- Liaising with vendors and ensuring study patients' protection and data integrity

- Monitoring data for missing or implausible entries and ensuring audit readiness

- Preparing accurate and timely trip reports and managing small projects

- Serving as lead monitor for a protocol or project and assisting in establishing monitoring plans

- Reviewing progress of projects and initiating actions to achieve target objectives

- Organizing and making presentations at Investigator Meetings

- Participating in protocol development and writing clinical trial reports

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

- Acting as contact for clinical trial supplies and other suppliers

- Managing registry management and undertaking feasibility work

- Conducting Quality Control visits and tracking Serious Adverse Event reporting

- Independently performing CRF review and query generation

- Assisting with training and mentoring new employees

The Senior CRA I should possess:

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

- At least 3 years of clinical research experience in the pharmaceutical or CRO industries

- 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 good planning and organization skills

- Good computer skills and advanced verbal and written communication skills

- Valid Driver's License

Travel requirements: 60-80% overnight.

## Skills

### Required
- clinical research
- site monitoring
- study management
- regulatory guidelines
- data integrity
- audit readiness
- project management
- communication skills
- registry management

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

---

Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Beijing/FSP-SCRA-I--Beijing-_266101?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)