Clinical Trials Lead (Lead Clinical Research Associate)

Avania

21d•$140,000

About The Position

As Clinical Trials Lead (Lead Clinical Research Associate), you will work with a sponsoring company in the monitoring of medical device and MedTech studies with an emphasis placed on ensuring the highest ethical and clinical standards. You will also assume a key role in the monitoring team by supervising project-specific monitoring activities, coordinating project-specific training, and interacting with our clients. Avania's Lead Clinical Research Associate (CTL / Lead CRA) acts as the primary contact for study questions from the monitoring team, organizes team training and study updates, and generates necessary monitoring tools. You will ensure monitoring visits are being conducted as needed and tasks are being completed in an appropriate and timely manner. Further, you will complete peer review of required study documentation to ensure these are accurate, complete, and of high quality. You will also represent Avania on study conference calls and/or meetings. The Lead CRA will collaborate with the Project Manager to ensure study objectives are met. You may also handle CRA study activities as needed. Finally, you will provide CRA support, including such activities as assisting Clinical Research Associates with difficult or challenging situations or corrective actions, conducting co-visits and providing feedback, reviewing monitoring reports, and similar work.

Requirements

This position requires travel approximately 25 – 30% of the time.

Responsibilities

Supervising project-specific monitoring activities
Coordinating project-specific training
Interacting with clients
Acting as the primary contact for study questions from the monitoring team
Organizing team training and study updates
Generating necessary monitoring tools
Ensuring monitoring visits are being conducted as needed
Ensuring tasks are being completed in an appropriate and timely manner
Completing peer review of required study documentation
Representing Avania on study conference calls and/or meetings
Collaborating with the Project Manager to ensure study objectives are met
Handling CRA study activities as needed
Providing CRA support, including such activities as assisting Clinical Research Associates with difficult or challenging situations or corrective actions, conducting co-visits and providing feedback, reviewing monitoring reports, and similar work