Study Start Up Associate II
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Job Description
Study Start Up Associate leading clinical trial regulatory initiation for ICON’s global healthcare research organization. Managing submissions, approvals, and site activation across North American studies.
Responsibilities:
- Lead the initiation of clinical trials, ensuring compliance with regulatory requirements
- Contribute to site start-up and activation activities, taking responsibility for deliverables and working collaboratively
- Lead preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
- Coordinate and liaise with internal and external stakeholders to obtain approvals and authorizations for study initiation
- Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence
- Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities
- Participate 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
- Willingness to travel as required (approximately 5%)
- Legal right to work in the country where the role is based
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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