# Senior CRA I

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

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Tokyo/Sr-Clinical-Research-Associate-_264267?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_6d3724e4-44c

## Description

We are seeking a Senior CRA I to oversee site monitoring and management for clinical studies. As a Senior CRA I, you will be responsible for ensuring the implementation of project plans, acting as a leader for projects of limited scope, and assuming line management responsibilities as assigned.

**Responsibilities:**

- Conduct site monitoring and management according to Fortrea and Sponsor Standard Operating Procedures and Regulatory Guidelines

- Ensure the protection of study patients by verifying informed consent procedures and protocol requirements

- Monitor data for missing or implausible data and ensure the integrity of data submitted on Case Report Forms

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

- Serve as lead monitor for a protocol or project and assist in establishing monitoring plans

- Review progress of projects and initiate actions to achieve target objectives

- Organize and make presentations at Investigator Meetings

- Participate in the development of protocols and Case Report Forms

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

- Act as contact for clinical trial supplies and other suppliers

- Track and follow-up on Serious Adverse Event reporting

- Independently perform CRF review and query generation and resolution

- Assist with training and development of new employees

- Coordinate designated clinical projects as a Local Project Coordinator

**Requirements:**

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

- 3 years of Clinical Monitoring experience

- Thorough knowledge of regulatory requirements and the drug development process

- Fluent in local office language and in English

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

- Ability to work with minimal supervision and good planning and organization skills

- Valid Driver's License

**Preferred Qualifications:**

- Additional experience in a related field

- Local project coordination and/or project management experience

## Skills

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

### 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/Tokyo/Sr-Clinical-Research-Associate-_264267?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)