Study Start Up Associate I

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

📋 Description

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

• Execute site start-up and activation tasks to meet high-quality benchmarks.

• Prepare and file regulatory documents, which include clinical trial applications and submissions to ethics committees.

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

• Keep precise and current records of all regulatory submissions and approvals.

• Assist study teams in crafting protocols, informed consent documents, and investigator brochures.

• Engage in study start-up meetings, providing insights on regulatory requirements and timelines.

⛳️ Requirements

• A bachelor's degree in life sciences or a related discipline is required.

• Prior experience in clinical research or regulatory affairs is preferred, though not mandatory.

• Exceptional attention to detail and strong organizational capabilities are essential.

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

• Capacity to work independently while managing multiple tasks concurrently in a dynamic environment.

• 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 assurance and disability coverage.

• Employee assistance programs and wellness resources.

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