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.

• Assist in site initiation and activation tasks.

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

• Collaborate with both internal and external stakeholders to secure approvals and authorizations for the initiation of studies.

• Manage and maintain documentation related to regulatory submissions, approvals, and correspondence.

• Offer guidance and support to study teams regarding regulatory requirements and best practices for study initiation.

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

⛳️ Requirements

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

• A minimum of 2 years' experience in clinical research or regulatory affairs, specifically in study start-up activities.

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

• Proven experience in ethics submissions and managing the ethical review process for clinical studies conducted at study sites in the United States.

• Exceptional organizational and project management abilities, with a knack for prioritizing and managing multiple tasks concurrently.

• Strong communication and interpersonal skills, enabling effective collaboration with cross-functional teams.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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