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:
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- 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.
