Fortrea is a premier global contract research organization (CRO) with a steadfast commitment to scientific excellence and innovation. With over 18,000 professionals operating in 90+ countries, Fortrea collaborates with pharmaceutical, biotechnology, and medical device industries to revolutionize drug and device development. Offering services across more than 20 therapeutic areas, Fortrea ensures that cutting-edge therapies and technologies reach patients swiftly and efficiently.

Key Responsibilities of the Role

As a Site Readiness and Regulatory Specialist II, you will contribute to Fortrea’s mission by managing critical regulatory and clinical trial submissions. Key duties include:

• Understanding and adhering to regulatory legislation and guidance.
• Preparing clinical trial applications under European Clinical Trials Regulation No 536/2014 via the Clinical Trial Information System (CTIS).
• Completing and uploading Part I and Part II documentation to CTIS with precision.
• Monitoring alerts in CTIS and informing the Global Regulatory Submissions Lead (GRSL) promptly.
• Tracking submissions and approvals using established tools.
• Ensuring timely updates of documents and systems for audit readiness.
• Escalating study issues in a timely manner.
• Participating in team meetings and other duties as assigned.

Qualifications and Skills Required

To excel in this role, candidates must possess the following qualifications and skills:

Educational Qualifications

• A bachelor’s degree in a relevant field (e.g., Life Sciences, Clinical Research, or equivalent).

Professional Skills

• Knowledge of European regulatory requirements and clinical trial submission processes.
• Experience with clinical trial applications, particularly using CTIS.
• Exceptional organizational and attention-to-detail skills for document management and review.
• Proficiency in tracking tools and document management systems.

Personal Attributes

• A proactive approach to problem-solving and issue escalation.
• Strong communication skills to collaborate effectively with internal teams.
• Adaptability and willingness to take on new responsibilities.

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