# Senior Clinical Research Associate II (Sr CRA II)

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

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Madrid/Senior-Clinical-Research-Associate-II---FSP-Oncology--Ophthalmology--and-or-Gene-Therapy---Madrid_266407?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

We are seeking a Senior Clinical Research Associate II (Sr CRA II) to join our team in Madrid. As a Sr CRA II, you will be responsible and accountable for site monitoring and site management for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.

**Summary of Responsibilities:**

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

- Liaise with vendors and ensure the protection of study patients by verifying informed consent procedures and protocol requirements

- Ensure data integrity by reviewing source documents and monitoring data for missing or implausible entries

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

- Prepare accurate and timely trip reports and serve as lead monitor for a protocol or project

- Review project progress and initiate actions to achieve target objectives

- Organize presentations at Investigator Meetings and participate in protocol development and Case Report Form creation

- Act as contact for clinical trial supplies and registry management

- Conduct Quality Control visits and track Serious Adverse Event reporting

- Independently perform CRF review and query generation

- Assist with training and mentoring new employees

- Coordinate clinical projects as a Local Project Coordinator

**Qualifications (Minimum Required):**

- University or college degree in a related allied health profession, or equivalent experience

- Minimum 6 years of recent clinical monitoring experience, with 2 years in Oncology, Ophthalmology, and/or Gene Therapy

- Thorough knowledge of regulatory requirements and the drug development process

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

**Experience (Minimum Required):**

- Five years of Clinical Monitoring experience, with 2 years in Oncology, Ophthalmology, and/or Gene Therapy

- Understanding of Serious Adverse Event reporting and good computer skills

- Ability to train and supervise junior staff, and prioritize workload

**Physical Demands/Work Environment:**

- Travel Requirement: Yes

## Skills

### Required
- Clinical Monitoring
- Regulatory Requirements
- Drug Development Process
- English
- Spanish

### Nice to have
- Oncology
- Ophthalmology
- Gene Therapy

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Madrid/Senior-Clinical-Research-Associate-II---FSP-Oncology--Ophthalmology--and-or-Gene-Therapy---Madrid_266407?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)