Study Start Up Associate II role supporting North American clinical trial initiation. Lead regulatory document preparation and site activation activities, coordinating with stakeholders to ensure compliance and advance innovative treatment development.
Responsibilities
Lead preparation and submission of regulatory documents including trial applications and ethics committee submissions
Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
Maintain comprehensive records of regulatory submissions, approvals, and correspondence
Provide guidance to study teams on regulatory requirements and start-up best practices
Participate in process improvement initiatives to enhance study start-up efficiency
Requirements
Bachelor's degree in life sciences or related field
Minimum 2 years clinical research or regulatory affairs experience with study start-up focus
Strong knowledge of ICH-GCP and local regulatory requirements for clinical trials
Excellent organizational and project management skills with multitasking ability
Strong communication and interpersonal skills for cross-functional collaboration
Willingness to travel approximately 5% as required

📌 Study Start Up Associate Ii (Xico)
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📍 Xico