# Senior CRA I

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

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Singapore/Sr-CRA-I_265307?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_02da8925-cc8

## Description

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

Responsibilities:

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

- Maintain study files and conduct 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

- Review data for missing or implausible data

- Monitor data for quality and ensure audit readiness at the site level

- Travel, including air travel, may be required

- 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

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

- Organize and make presentations at Investigator Meetings

- Participate in protocol development and writing clinical trial reports

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

- Act as contact for clinical trial supplies and other suppliers

- Responsible for registry management

- Undertake feasibility work and conduct Quality Control visits

- Recruit potential investigators and prepare EC submissions

- Negotiate study budgets with potential investigators

- 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 life science or related field

- Certification in a related allied health profession or nursing certification

- 3 years of relevant clinical research experience

- Thorough knowledge of regulatory requirements

- Understanding of the drug development process

- Fluent in local office language and English

Experience:

- 3 years of Clinical Monitoring experience

- Advanced site monitoring skills

- Advanced study site management skills

- Ability to work with minimal supervision

- Good planning and organization skills

- Good computer skills

- Advanced verbal and written communication skills

- Ability to train and supervise junior staff

Physical Demands/Work Environment:

- Travel requirements: 60-80% overnight

## Skills

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

### 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/Singapore/Sr-CRA-I_265307?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)