# Document Review Specialist II

**Company**: Fortrea
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Bucharest/ICF-Reviewer-II_265334?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_1769816d-291

## Description

We are seeking a Document Review Specialist II to review Informed Consent Forms and Advertisements following project and country-specific regulations as well as ICH-GCP, FDA and other regional guidance.

Responsibilities:

- Review Country/Site Informed Consent Form to ensure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.

- Review Patient Recruiting materials (Advertisements) to ensure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.

- File Informed Consent Form, Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF.

- Review protocol amendment to reconfirm completeness and ensure compliance with Good Clinical Practice (GCP) guidelines.

- Review revised Core Informed Consent Forms to reconfirm compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.

- Provide input for Corrective and Preventative Actions (CAPAs) related to Document Review activities.

Qualifications:

- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution.

- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.

- 2+ years' work experience in clinical research.

- Previous interaction with operational project teams preferred.

Preferred Qualifications:

- Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services).

- Good written and oral communication skills.

- Well-developed organizational skills.

- Excellent proof-reading skills.

- Good time management skills with ability to consistently prioritize workload to accommodate multiple tasks and projects.

- Ability to work independently within a flexible team environment.

- Accuracy and Attention to detail.

- Analytical and problem-solving skills.

Physical Demands/Work Environment:

- Standard office environment.

## Skills

### Required
- ICH
- FDA
- IRB/IEC
- GCP
- Clinical Research

### Nice to have
- MS Office
- Communication
- Organizational
- Proof-reading
- Time Management
- Analytical
- Problem-solving

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Bucharest/ICF-Reviewer-II_265334?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)