Phase I Clinical Start-Up Specialist - Regulatory & Site Activation

Fortrea; United States; Remote; USD 50,000 - 70,000; Full time

Job summary

Fortrea seeks a Study Start Up Specialist in the United States to coordinate regulatory submissions and collect essential documents for site activation and ongoing maintenance. You will ensure compliance with EC/IRB/Regulatory Authority requirements, track timelines, and act as a local expert across start-up activities.

This role involves mentoring teammates, drafting country applications, and collaborating with vendors to prepare audit-ready documentation in a fast-paced, technology-driven

Qualifications

• Bachelor’s degree in life sciences or related field, or equivalent experience.
• At least 2 years in clinical research with ICH guidelines and RA/IRB/IEC regulations.
• Experience in start-up/regulatory process for clinical trials.
• Familiarity with investigator start-up documents and contract/budget negotiation.
• Ability to communicate protocol requirements and educate others.

Responsibilities

• Primary contact with investigative sites during start-up and maintenance to ensure timely submissions.
• Coordinate data collection for EC/IRB/Regulatory Authority submissions and country applications.
• Liaise with internal/external vendors for regulatory submissions and final document quality reviews.
• Ensure start-up activities meet laws, guidelines, ICH/GCP, SOPs and sponsor expectations.
• Mentor and train new hires; support site activation strategy and timelines.

Skills

Regulatory knowledge

ICH/GCP guidance

IRB/IEC regulations

Site start-up documentation

Education

Life science degree

Job description

Fortrea seeks a Study Start Up Specialist in the United States to coordinate regulatory submissions and collect essential documents for site activation and ongoing maintenance. You will ensure compliance with EC/IRB/Regulatory Authority requirements, track timelines, and act as a local expert across start-up activities.

This role involves mentoring teammates, drafting country applications, and collaborating with vendors to prepare audit-ready documentation in a fast-paced, technology-driven