# 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/FSP-SCRA-I-Changsha-_2447386?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_379161a6-928

## Description

The Senior CRA I is responsible for site monitoring and site management, ensuring the implementation of project plans, and acting as a leader for projects of limited scope.

**Responsibilities:**

- Conduct site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, and liaison with vendors

- Manage site management activities as prescribed in project plans

- 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 entries

- Perform monitoring tasks efficiently, according to SOPs and established guidelines

- Prepare accurate and timely trip reports

- Manage small projects under the direction of a Project Manager/Director

- Serve as lead monitor for a protocol or project

- Participate in protocol development and case report form creation

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

- Act as contact for clinical trial supplies and vendors

- Track and follow up on Serious Adverse Event (SAE) reporting

- Independently perform CRF review and query generation

- Assist with training and mentoring new employees

**Qualifications:**

- University or college degree in life sciences or 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 prioritize workload

- Good planning, organization, and communication skills

- Valid driver's license

**Physical Demands/Work Environment:**

- Travel requirements: 60-80% overnight

## Skills

### Required
- clinical monitoring
- site management
- regulatory requirements
- drug development process
- English

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

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Shanghai/FSP-SCRA-I-Changsha-_2447386?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)