# Site Start-Up Specialist

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

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Remote-Sweden/Site-Start-up-Specialist---FSP_265404?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_dc051a16-638

## Description

Join Fortrea and drive clinical research success as a Site Start-Up Specialist. You will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently.

In this role, you will be part of the FSPx team and work directly with a renowned key sponsor to advance the development of innovative, life-changing medications.

**Key Responsibilities:**

- Serve as the primary contact for investigative sites during start-up and maintenance activities.

- Collect, review, and organize essential documents required for regulatory submissions.

- Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.

- Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.

- Track submission timelines and proactively address potential delays.

- Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.

- Ensure all documentation is audit-ready and systems are consistently updated.

- Assist in the negotiation of site contracts and budgets, if applicable.

- Provide mentorship and training to new hires and less-experienced colleagues.

**Required Qualifications:**

- University/College degree (life sciences preferred) or certification in a related allied health profession.

- Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.

- Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.

- Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements.

- Experience interacting with regulatory authorities and site start-up teams.

- Excellent organizational, problem-solving, and communication skills.

- Proficiency in Microsoft Office and document management systems.

- Fluency in local language and English.

**What We Offer:**

- Competitive salary and performance-based incentives.

- Flexible work arrangements (remote/hybrid options).

- Professional growth opportunities in a collaborative and innovative environment.

- The opportunity to work on cutting-edge clinical research projects.

## Skills

### Required
- ICH/GCP guidelines
- regulatory submissions
- site activation
- Microsoft Office
- document management systems
- English

---

Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Remote-Sweden/Site-Start-up-Specialist---FSP_265404?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)