Clinical Operations Specialist

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

📋 Description

• Assist in the initiation and activation of site activities, taking ownership of deliverables and collaborating effectively.

• Oversee the preparation and submission of regulatory documents, which include clinical trial applications, ethics committee submissions, and communications with regulatory agencies.

• Coordinate and communicate with both internal and external stakeholders to secure the necessary approvals and authorizations for commencing studies.

• Manage and uphold thorough and precise records of regulatory submissions, approvals, and correspondence.

• Offer guidance and support to study teams regarding regulatory requirements and best practices for study initiation activities.

• Engage in process improvement initiatives aimed at refining study start-up processes and improving overall 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, particularly in study start-up activities.

• Strong knowledge of regulatory requirements 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 simultaneously.

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

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

• Employment with ICON is contingent upon having the legal authority 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 plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.