Clinical Operations Specialist

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

📋 Description

• Oversee the initiation of clinical trials, ensuring adherence to regulatory standards.

• Assist in site start-up and activation processes.

• Prepare and file regulatory documents, such as clinical trial applications, ethics committee submissions, and communications with regulatory agencies.

• Collaborate with both internal and external stakeholders to secure necessary approvals and authorizations for the commencement of studies.

• Organize and maintain documentation related to regulatory submissions, approvals, and correspondence.

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

• Engage in process enhancement initiatives aimed at optimizing study start-up procedures and boosting efficiency.

⛳️ Requirements

• A bachelor's degree in life sciences or a related discipline.

• At least 2 years of experience in clinical research or regulatory affairs, specifically in study start-up activities.

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

• Exceptional organizational and project management abilities, with the capacity to prioritize and handle multiple tasks concurrently.

• Outstanding communication and interpersonal skills, with a strong ability to work collaboratively with cross-functional teams.

• Readiness to travel as necessary (approximately 5%).

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career advancement paths.