# Clinical Research Associate

**Company**: Fortrea
**Location**: Sydney
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Sydney/Unblinded-Clinical-Research-Associate-I_266467?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_be9132df-f7b

## Description

We are seeking a Clinical Research Associate to support unblinded monitoring activities for FSP MSD clinical studies.

The successful candidate will be primarily responsible for site monitoring and site management, ensuring the implementation of project plans, and adhering to Company and Sponsor Standard Operating Procedures and Regulatory Guidelines.

Key responsibilities include:

- Conducting routine monitoring and closeout of clinical sites

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

- Liaising with vendors and other stakeholders

- Ensuring the protection of study patients and the integrity of data submitted

- Monitoring data for missing or implausible data

- Ensuring audit readiness at the site level

- Traveling to clinical sites, including air travel, as required

- Preparing accurate and timely trip reports

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

- Acting as a contact for clinical trial supplies and other suppliers

- Managing investigator site budgets

- Tracking and following up on Serious Adverse Event reporting

- Performing CRF review and query generation and resolution

- Assisting with training and development of new employees

- Coordinating designated clinical projects as a Local Project Coordinator

The ideal candidate will have:

- A university or college degree in a related allied health profession

- Basic knowledge of Regulatory Guidelines and the clinical trial process

- Fluent in local office language and in English, both written and verbal

- Six months experience in a related role

- Good planning, organization, and problem-solving skills

- Good computer skills with good working knowledge of a range of computer packages

- Valid Driver's License

Preferred qualifications include:

- Additional experience in a related field

- On-site monitoring experience

- Ability to maintain confidentiality of data and information

- Demonstrated ability to conduct clinical operations activities effectively and efficiently

- Attention to detail and methodical approach to work

- Understanding of medical and clinical research terminology and clinical research processes

## Skills

### Required
- Regulatory Guidelines
- clinical trial process
- site management
- data analysis

### Nice to have
- on-site monitoring
- confidentiality
- clinical operations
- medical research terminology

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Sydney/Unblinded-Clinical-Research-Associate-I_266467?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)