# Senior CRA I

**Company**: Fortrea
**Location**: Melbourne
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Melbourne/Sr-Clinical-Research-Associate-I--Sydney--Melbourne--or-Perth_263669-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_c9225882-7dc

## Description

The Senior CRA I is responsible for site monitoring and site management of clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.

The Senior CRA I will assure the implementation of project plans, act as a leader for 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 other stakeholders

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

- Monitoring data for missing or implausible entries

- Managing travel expenses and ensuring audit readiness at the site level

- Preparing accurate and timely trip reports

- Managing small projects and serving as a lead monitor for a protocol or project

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

- Organizing and making presentations at Investigator Meetings

- Participating in the development of protocols and Case Report Forms

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

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

- Undertaking feasibility work and conducting Quality Control visits

- Recruiting potential investigators and preparing EC submissions

- Negotiating study budgets with potential investigators

- Tracking and following up on Serious Adverse Event reporting

- Independently performing CRF review and query generation and resolution

- Assisting with training and mentoring of new employees

The ideal candidate will have:

- A university or college degree in life sciences or a related field

- 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 English and local office language skills

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

- Ability to work with minimal supervision and prioritize workload

- Good planning and organization skills, computer skills, and verbal and written communication skills

- Valid Driver's License

Preferred qualifications include:

- Additional experience in a related field

- Local project coordination and/or project management experience

The physical demands of the job include:

- 60-80% overnight travel requirements

## Skills

### Required
- clinical research
- regulatory requirements
- drug development process
- site monitoring
- study site management
- registry administration
- 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/Melbourne/Sr-Clinical-Research-Associate-I--Sydney--Melbourne--or-Perth_263669-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)