# Senior Clinical Research Associate II (Sr CRA II)

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

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Sydney/Sr-Clinical-Research-Associate-II--SCRA2---FSP---Sydney-or-Melbourne_266462?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_f85ff66a-3ba

## Description

We are seeking a Senior Clinical Research Associate II (Sr CRA II) to work on a dedicated sponsor project. As a Sr CRA II, you will be responsible for Risk-based Monitoring (RBM) and site management for clinical studies according to sponsor Standard Operating Procedures and Regulatory Guidelines.

**Responsibilities:**

- Conduct routine monitoring and close-out of clinical sites, maintenance of study files, and pre-study and initiation visits

- Liaise with vendors and manage study site management 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 data

- Manage travel expenses efficiently according to Fortrea's travel policy

- 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, Case Report Form creation, and clinical trial report writing

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

- Act as contact for clinical trial supplies and vendors

- Perform registry management, feasibility work, and Quality Control visits

- Recruit potential investigators, prepare EC submissions, and negotiate study budgets

- 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 a related allied health profession (e.g., nursing licensure)

- Alternatively, 6 years of recent 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

**Preferred Qualifications:**

- Local project coordination and/or project management experience

- Ability to maintain confidentiality and demonstrate clinical operations activities

- Strong understanding of medical and clinical research terminology

- Experience using a clinical trial management system (CTMS)

**Physical Demands/Work Environment:**

- Travel required for site monitoring visits

## Skills

### Required
- clinical research
- regulatory requirements
- site management
- data integrity
- CRF review

### Nice to have
- local project coordination
- project management
- clinical trial management system
- medical terminology

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Sydney/Sr-Clinical-Research-Associate-II--SCRA2---FSP---Sydney-or-Melbourne_266462?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)