Study Start Up Associate

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Study Start Up Associate in Canada.

This role offers an exciting opportunity to contribute to the successful launch of clinical research studies that help bring innovative therapies and treatments to patients. As part of a collaborative and fast-paced research environment, you will support the regulatory and operational activities required to initiate clinical trials efficiently and in compliance with applicable guidelines. Working closely with internal teams, sponsors, investigators, and regulatory bodies, you will help ensure study start-up milestones are achieved on time. The position combines project coordination, regulatory documentation, and stakeholder engagement, making it ideal for professionals who enjoy both detail-oriented work and cross-functional collaboration. Your contributions will directly impact the speed and quality of clinical trial activation. This is an excellent opportunity to develop expertise within clinical research while supporting meaningful advancements in healthcare.

• Assist in the preparation, review, and submission of regulatory documentation, including clinical trial applications and ethics committee submissions.
• Coordinate with internal teams, study sites, investigators, and external stakeholders to secure required approvals and authorizations for study initiation.
• Maintain accurate and up-to-date records of regulatory submissions, approvals, and study start-up documentation.
• Support the development and maintenance of essential study documents, including protocols, informed consent forms, investigator brochures, and related materials.
• Participate in study start-up meetings and provide guidance regarding regulatory requirements, timelines, and submission processes.
• Monitor study start-up activities to ensure compliance with applicable regulations, procedures, and project deadlines.
• Contribute to the efficient activation of clinical trials by proactively identifying and resolving start-up challenges.

Requirements:

• Bachelor's degree in Life Sciences, Health Sciences, or a related field.
• At least 1 year of experience in Study Start-Up (SSU) activities within clinical research.
• Previous experience in clinical research, clinical operations, regulatory affairs, or a related environment is preferred.
• Strong understanding of clinical trial start-up processes and regulatory documentation requirements.
• Excellent organizational skills with exceptional attention to detail and accuracy.
• Strong verbal and written communication skills, with the ability to collaborate effectively across multidisciplinary teams.
• Advanced French language proficiency, including strong written and verbal communication skills for regulatory submissions and study documentation.
• Ability to work independently, manage competing priorities, and perform effectively in a fast-paced environment.
• Proficiency with standard business applications and clinical research systems is an asset.

Benefits:

• Competitive salary and performance-related incentive opportunities.
• Remote work flexibility within Canada.
• Comprehensive health, dental, and vision coverage, where applicable.
• Life insurance and disability protection programs.
• Retirement and pension savings plans.
• Employee assistance programs and well-being resources.
• Ongoing learning and professional development opportunities.
• Structured career progression pathways within clinical research and operations.
• Inclusive and collaborative work environment focused on growth and innovation.
• Opportunity to contribute to impactful clinical research that advances patient care worldwide.