Clinical Research Associate II - Site Start Up and EUCTR Submission

Site Start up EUCTR II/ Initiation Clinical Research Associate II

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Site Start Up EUCTR II

• Responsible for planning and submitting the complex EUCTR submission i.e. large phase II and III trials with multiple countries and sites.

Job Requirements: In addition to the core duties outlined, the following qualifications are required for the Site Start Up EUCTR II

• Interpersonal & leadership skills

• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
• A data driven approach to planning, executing, and problem solving
• Effective communication skills via verbal, written and presentation abilities
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to build productive study teams collaborations
• Vendor management experience
• Basic proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel
• Experience in the clinical drug development process, including study start-up
• Knowledge of ICH/GCP, EUCTR and IVDR regulatory guidelines
• Basic project management skills, cross-functional team interaction and organizational skills
• May require up to 25% travel
• Bachelor’s degree and 3-4 years of relevant experience.

Experience Level

Mid Level