Study Start Up Associate

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

📋 Description

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

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

• Aid in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.

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

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

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

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

⛳️ Requirements

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

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

• Exceptional attention to detail and strong organizational capabilities.

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

• Capacity to work independently and juggle multiple tasks in a fast-paced 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 insurance and disability coverage.

• Employee assistance programs and wellness resources.

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