Study Start Up Associate I

As a Study Start Up Associate I at ICON Strategic Solutions in Buenos Aires, Argentina, you will facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

Key Responsibilities:

• Coordinate country and site start-up activities against study timelines.
• Collect, review, and track essential regulatory and site documents.
• Support ethics, regulatory, and site submission activities as applicable.
• Identify start-up risks and follow actions through resolution.
• Maintain accurate status and documentation in relevant clinical systems.

Requirements:

• Bachelor's degree in life sciences or a related field.
• Relevant life sciences, healthcare, regulatory, or clinical research experience.
• Knowledge of ICH Good Clinical Practice (GCP) and clinical study start-up processes.
• Experience coordinating site activation, regulatory submissions, or essential documents.
• Experience coordinating country and site start-up activities against study timelines.
• Experience supporting ethics, regulatory, and site submission activities as applicable.
• Experience identifying start-up risks and following actions through resolution.
• Experience with local ethics committee or regulatory submission requirements (Argentina).
• Experience in Clinical Research, Study Start-Up, Site Activation, or Regulatory Affairs.
• Able to review protocols and study documents in both Spanish and English.

Preferred Qualifications:

• Site contract or budget experience.
• Clinical trial management systems (CTMS), electronic Trial Master File (eTMF), or start-up platform experience.

Working Conditions:

• Home-based from Argentina.

Rewards & Benefits:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.