Study Start Up Associate II

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

📋 Description

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

• Assist in site start-up and activation processes.

• Prepare and submit regulatory documents, which include clinical trial applications and ethics committee submissions.

• Maintain communication with regulatory authorities.

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

• Maintain precise records of regulatory submissions, approvals, and correspondence.

• Offer guidance and support to study teams regarding regulatory requirements and best practices for study start-up.

• Engage in process improvement initiatives aimed at optimizing study start-up procedures and boosting 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, specifically in study start-up activities.

• Strong knowledge 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 U.S. study sites.

• Exceptional organizational and project management skills, with the ability to prioritize and handle multiple tasks concurrently.

• Excellent communication and interpersonal skills, with the capability to collaborate effectively across 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 plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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