Associate Clinical Trials Administrator

About the role

The Associate Clinical Trial Administrator supports the Clinical and Medical Affairs team by providing general administrative support, including updating clinical project progress, managing Engineering Change Orders (ECOs), preparing and sending documents, reviewing invoices, and organizing meetings.

Responsibilities

• Updates the clinical project progress using tracking tools provided by the project leads from the Clinical and Medical Affairs team.
• Structure development of the tracking tools.
• Creates and initiates Engineering Change Orders (ECOs).
• Follows up the ECO process and document release.
• Helps with creating redlined documents and drafting the change history.
• Packages and sends documents and materials to clinical trial sites and vendors as needed.
• Reviews clinical study documents for accuracy and compliance with company SOPs, ISO standards, industry guidelines and regulations.
• Maintains trackers and archives historical versions.
• Ensures invoices are accurate and compliant with executed contracts, communicates with vendors and clinical trial sites for discrepancies, and follows up with the accounting team for payment status updates.
• Organizes and manages internal team meetings, investigator meetings, and other clinical trial-specific meetings.
• Performs general support to the Clinical and Medical Affairs team as needed.
• Maintains trained status for, and complies with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.

Qualifications

• Bachelor’s degree in a scientific or health care discipline preferred and/or training; or equivalent combination of education and experience.
• 1-2 years’ experience in the medical device industry with involvement in clinical research activities preferred.
• Superb verbal and written communications skills.
• Excellent organizational skills along with strong attention to detail.
• Ability to work both independently and collaboratively in a team environment.
• Highly proficient with Microsoft office Suite.
• Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
• Utilizes critical thinking to analyze problems which may require multiple factors and approaches.