Remote Site Start-Up Specialist: Regulatory Submissions

Fortrea; United States; Remote; USD 65,000 - 95,000; Full time

Benefits offered by this job

Flexible work arrangements (remote/hy-

Job summary

Fortrea is seeking a Site Start-Up Specialist to coordinate start-up activities and regulatory submissions for investigative sites. The role requires organizing essential documents, ensuring ICH/GCP compliance, and tracking timelines with vendors and regulators.

The position is full-time, home-based with flexible remote/hybrid options and Nordic language support preferred. A life sciences degree and 2+ years in clinical research are desired.

Qualifications

• University/college degree in life sciences or related field.
• Experience with regulatory submissions and site activation processes is required.
• Strong organizational and communication skills with attention to detail.

Responsibilities

• Serve as primary contact for investigative sites during start-up and maintenance activities.
• Collect, review, and organize essential regulatory documents for submissions.
• Prepare and submit country-specific regulatory documents and informed consent forms.

Skills

Regulatory Submissions

ICH/GCP

Site Activation

Documentation Management

Project Coordination

Communication

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Document Management Systems

Job description

Fortrea is seeking a Site Start-Up Specialist to coordinate start-up activities and regulatory submissions for investigative sites. The role requires organizing essential documents, ensuring ICH/GCP compliance, and tracking timelines with vendors and regulators.

The position is full-time, home-based with flexible remote/hybrid options and Nordic language support preferred. A life sciences degree and 2+ years in clinical research are desired.