Study Start Up Associate II

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Oversee the commencement of clinical trials, ensuring adherence to regulatory standards.

• Play an active role in site initiation and activation efforts, taking ownership of deliverables and collaborating effectively.

• Draft and submit regulatory documentation, such as clinical trial applications, ethics committee submissions, and communications with regulatory agencies.

• Coordinate and communicate with both internal and external stakeholders to secure approvals and authorizations for study initiation.

• Manage and uphold thorough and precise records of regulatory submissions, approvals, and communications.

• Offer guidance and support to study teams on regulatory standards and best practices for study initiation activities.

• Engage in process improvement initiatives aimed at optimizing study start-up processes and enhancing overall efficiency.

⛳️ Requirements

• A Bachelor’s degree in life sciences or a related discipline.

• At least 2 years of experience in clinical research or regulatory affairs, with a focus on study initiation activities.

• Strong knowledge of regulatory standards and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.

• Exceptional organizational and project management abilities, with the capacity to prioritize and handle multiple tasks at once.

• Outstanding communication and interpersonal skills, with the capability to collaborate effectively with cross-functional teams.

• Willingness to travel as needed (approximately 5%).

• Employment with ICON is contingent upon possessing the legal right to work in the country where the role is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.