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Study Start Up Associate
hace 2 meses
Job Summary:
ICON is seeking a highly skilled and experienced Study Start Up Associate II to join our dynamic team. As a Study Start Up Associate II, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.
Key Responsibilities:
- Regulatory Document Preparation: Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
- Stakeholder Coordination: Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
- Record Management: Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
- Regulatory Guidance: Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
- Process Improvement: Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency.
Requirements:
- Education: Bachelor's degree in life sciences or a related field.
- Experience: Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
- Skills: 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.
What ICON Offers:
- Competitive Salary: A competitive salary that reflects your skills and experience.
- Benefits Package: A comprehensive benefits package that includes various annual leave entitlements, health insurance offerings, retirement planning options, and more.
- Professional Development: Opportunities for professional development and growth within the company.
Equal Opportunities Employer:
ICON is an equal opportunities employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
