Regulatory Start-Up Specialist II

Fortrea; Turkey; On-site; TRY 40,000 - 60,000; Full time

Job summary

A leading company in clinical research is seeking a Regulatory Start-Up Specialist II in Istanbul. In this role, you will be the key expert for site start-up activities and regulatory submissions, collaborating with teams to ensure compliance and smooth operations. Ideal candidates will have a degree in life sciences and at least 2 years of relevant experience, along with strong organizational skills and a proactive approach to problem-solving.

Benefits

Flexible work environment

Continuous learning opportunities

Qualifications

• 2+ years of experience in clinical research or regulatory start-up.
• Solid knowledge of ICH-GCP, IRB/IEC, and regulatory requirements.

Responsibilities

• Serve as the primary contact for investigative sites during start-up.
• Prepare and manage essential regulatory documents for EC/IRB.
• Coordinate submissions and review site-specific informed consent forms.

Skills

Organizational skills

Attention to detail

Problem-solving

Education

Degree in life sciences

Job description

Regulatory Start-Up Specialist II

Location: office based, Istambul | Full-Time

Join our mission to advance clinical research.

We’re seeking a Regulatory Start-Up Specialist II to be the go-to expert for site start-up activities and regulatory submissions. In this dynamic role, you’ll collaborate with internal teams, ethics committees, and regulatory authorities to ensure smooth and compliant study start-ups across your region.

What You’ll Do:

• Serve as the primary contact for investigative sites during start-up and maintenance.
• Prepare and manage essential regulatory documents for EC/IRB and Regulatory Authorities.
• Coordinate submissions, review site-specific informed consent forms, and ensure compliance with local requirements.
• Track timelines, flag risks, and support the team with regulatory expertise.
• Act as a knowledge resource to train or mentor junior colleagues, when applicable.
• Conduct initial site outreach, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey
• Perform Remote Pre-Study Visits and follow up documentation, including visit preparation, trip report completion, and other documentation as required to support site selection in line with sponsor and protocol requirements.
• Perform initial contract and budget negotiations with the sites

What You Bring:

• 2+ years of experience in clinical research or regulatory start-up.
• Solid knowledge of ICH-GCP, IRB/IEC, and regulatory requirements.
• Degree in life sciences or equivalent experience.
• Strong organizational skills, attention to detail, and proactive problem-solving.

Nice to Have:

• Experience with IRAS, CTIS, or EU/UK regulatory systems.
• Familiarity with contract/budget negotiation processes.

Why Join Us?
You’ll be part of a dedicated, collaborative team driving impactful clinical studies. We offer a flexible work environment, continuous learning, and opportunities to grow within global trials.

Apply now to make a real difference in the future of health!

Learn more about our EEO & Accommodations request here .