Study Start Up Associate (Remote)

Job summary

The role involves leading the initiation of clinical trials while ensuring compliance with regulatory standards. The position is fully remote and focuses on site start-up and activation activities, requiring collaboration with various stakeholders.

Qualifications

• Bachelor's degree in life sciences or a related field.
• At least 2 years of experience in clinical research or regulatory affairs, specifically in study start-up activities.
• Strong knowledge of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulations.
• Excellent organizational and project management skills, capable of managing multiple tasks simultaneously.
• Strong communication and interpersonal skills for effective collaboration with cross-functional teams.
• Willingness to travel as needed (approximately 5%).

Responsibilities

Rewards & 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, approvals, and correspondence.
• Provide guidance to study teams on regulatory requirements and best practices for start-up activities.
• Participate in initiatives aimed at improving study start-up processes and efficiency.
• 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 through structured training.