Study Start Up Associate

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

📋 Description

• Oversee the initiation of clinical trials

• Engage in site start-up and activation processes

• Prepare and submit regulatory documents, such as clinical trial applications and submissions to ethics committees

• Collaborate with internal and external stakeholders to secure necessary approvals and authorizations for study initiation

• Maintain accurate records of regulatory submissions, approvals, and correspondence

• Offer guidance and support to study teams regarding regulatory requirements and best practices for study start-up

• Take part in initiatives aimed at improving processes to enhance the efficiency of study start-up

⛳️ Requirements

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

• At least 3 years of experience in clinical research or regulatory affairs, particularly in study start-up activities

• Strong comprehension of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulations

• Exceptional organizational and project management capabilities, with the ability to prioritize and handle multiple tasks at once

• Outstanding communication and interpersonal skills, enabling effective collaboration with cross-functional teams

• Legal authorization to work in Romania

🏝️ Benefits

• Competitive base salary

• 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 defined career pathways