Study Start Up Associate (Remote)

Job summary

The role involves leading the initiation of clinical trials and ensuring compliance with regulatory requirements to facilitate the advancement of new treatments.

Qualifications

• Bachelor's degree in life sciences or a related field.
• Minimum of 2 years of experience in clinical research or regulatory affairs, specifically in study start-up activities.
• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulations.
• Excellent organizational and project management skills.
• Strong communication and interpersonal skills.
• Willingness to travel approximately 5% as needed.

Responsibilities

Benefits

• Lead the preparation and submission of regulatory documents, including clinical trial applications and ethics committee submissions.
• Coordinate with internal and external stakeholders to secure necessary approvals for study initiation.
• Maintain accurate records of regulatory submissions and correspondence.
• Provide guidance to study teams on regulatory requirements and best practices.
• Participate in initiatives to improve study start-up processes.
• Competitive base salary and performance-related incentives.
• Health and wellbeing programs, including medical, dental, and vision coverage.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programs and wellbeing resources.
• Learning and development opportunities.