Study Start Up Associate II Specialist
hace 2 semanas
At Icon, we are seeking a highly skilled Study Start Up Associate II to join our team. This role is an exciting opportunity for individuals who are passionate about delivering high-quality results in a fast-paced environment.
Job Summary:
The Study Start Up Associate II will be responsible for collecting, preparing, reviewing, approving, processing, and tracking regulatory and site-level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines, and the principles of ICH/GCP.
This role requires a strong understanding of ICON SOPs/WPs, ICH/GCP, and applicable country regulations/guidelines. The ideal candidate will have excellent communication and negotiation skills, with the ability to work effectively with stakeholders to ensure successful project outcomes.
Key Responsibilities:
- Collect, prepare, review, approve, process, and track regulatory and site-level critical documents required for study site activation
- Negotiate Informed Consent Forms (ICFs) with study sites to ensure compliance with local requirements and regulations
- Prepare, review, and approve Global Master ICF templates for sponsors, as well as Country Master ICF templates inserting required country elements
- Negotiate Clinical Trial Agreements (CTAs) with study sites, including budgets and ancillary agreements
- Coordinate with Ethics Committees, Institutional Review Boards, and Country Regulatory Agencies to obtain necessary authorizations/approvals
- Perform timely and accurate task progress communication and data entry of all relevant study start-up activities into tracking systems
Requirements:
- Bachelor's degree in a life science or related field
- Minimum 2 years of experience in clinical research or a related field
- Strong understanding of ICON SOPs/WPs, ICH/GCP, and applicable country regulations/guidelines
- Excellent communication and negotiation skills
- Ability to work effectively in a team environment
Benefits:
- Competitive salary: $85,000 - $110,000 per year, depending on location and experience
- Opportunities for career growth and professional development
- A dynamic and supportive work environment
- Access to cutting-edge technology and resources
About Icon:
Icon is a global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. We offer a wide range of services, including clinical trial management, medical writing, and regulatory affairs.
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