Study Start Up Associate I

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

📋 Description

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

• Execute site start-up and activation tasks to a high level of quality.

• Prepare and file regulatory documents, such as 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 the development of protocols, informed consent forms, and investigator brochures.

• Engage in study start-up meetings and contribute insights regarding regulatory requirements and timelines.

⛳️ Requirements

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

• Prior experience in clinical research or regulatory affairs is preferred, but not essential.

• Exceptional attention to detail and strong organizational abilities.

• Outstanding communication and interpersonal skills, with the capacity to work collaboratively with cross-functional teams.

• Capability to work autonomously and handle multiple tasks simultaneously 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 options.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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