Study Start Up Associate II

This is a fully remote position, open to applicants in Brazil, +1 more country.

📋 Description

• Oversee the commencement of clinical trials

• Assist in site start-up and activation efforts

• Prepare and file regulatory documents, such as clinical trial applications and submissions to ethics committees

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

• Maintain precise records of regulatory submissions, approvals, and communications

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

• Engage in process enhancement initiatives to optimize study start-up procedures and improve 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, particularly in study start-up activities

• In-depth knowledge of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulations

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

• Strong communication and interpersonal skills, with the aptitude to collaborate effectively with cross-functional teams

• Willingness to travel as necessary (approximately 5%)

• 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

• Reasonable accommodations during the recruitment process