# CRA II

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

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Madrid/Clinical-Research-Associate-II---Madrid_265097?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_e5366f14-162

## Description

Fortrea's FSP team is currently seeking two CRA II professionals to join the team in Madrid.

The successful candidates will have at least 3-4 years of experience working on complex clinical trials, specifically within oncology: early phases/lung phase I/immunology/Gastrointestinal-Prostate-Bladder and renal cancer.

**Responsibilities:**

- Monitor study sites, including routine monitoring and closeout of clinical sites, maintenance of study files, and conduct of 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 that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements

- Review source documents to ensure data integrity

- Monitor data for missing or implausible data

- Ensure audit readiness at the site level

- Travel, including air travel, may be required

- Prepare accurate and timely trip reports

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

- Act as contact for clinical trial supplies and other suppliers

- Manage registry management as prescribed in project plans

- Undertake feasibility work when requested

- Participate in and follow-up on Quality Control Visits

- Recruit potential investigators, prepare EC submissions, and notify regulatory authorities

- Assist Senior CRA with managing investigator site budgets

- Track and follow-up on Serious Adverse Event reporting

- Independently perform CRF review and query generation and resolution

**Qualifications:**

- University degree in a scientific or medical field

- Thorough understanding of ICH GCP Guidelines and local regulatory requirements in Spain

- Fluent in Spanish and English, both written and verbal

**Experience:**

- Minimum 3-4 years of experience as an independent monitor, working specifically within oncology

- Basic understanding of Regulatory Guidelines

- Ability to work within a project team

- Good planning, organisation, and problem-solving skills

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

- Valid Driver's License

## Skills

### Required
- ICH GCP Guidelines
- Spanish
- English
- oncology
- Gastrointestinal
- Prostate
- Bladder
- renal cancer
- Clinical trials

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Madrid/Clinical-Research-Associate-II---Madrid_265097?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)