Clinical Research Associate
hace 4 semanas
Study Start Up Associate II Role
We are seeking a highly skilled Study Start Up Associate II to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization.
Key Responsibilities:
- Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
- Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
- Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
- Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
- Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.
Requirements:
- Bachelor's degree in life sciences or a related field.
- Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
- Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
- Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Fluency in English and Dutch.
What ICON Offers:
- Competitive salary and benefits package.
- Opportunities for career growth and professional development.
- A dynamic and inclusive work environment.
Why Choose ICON?
At ICON plc, we are committed to fostering a culture of innovation, excellence, and inclusivity. We believe in the importance of diversity and strive to create an environment where everyone feels valued and empowered to contribute their best work.
Apply Now:
If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].
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