Clinical Trials Lead (Lead Clinical Research Associate)

Avania•,

1d•Remote

About The Position

Avania is hiring a Clinical Trials Lead (Lead Clinical Research Associate) to work with a sponsoring company in the monitoring of medical device and MedTech studies. This role emphasizes ensuring the highest ethical and clinical standards. The Clinical Trials Lead will supervise project-specific monitoring activities, coordinate project-specific training, and interact with clients. They will serve as the primary contact for study questions from the monitoring team, organize team training and study updates, and create necessary monitoring tools. The role ensures monitoring visits and tasks are completed appropriately and in a timely manner. Additionally, the Lead CRA will perform peer reviews of study documentation for accuracy, completeness, and quality, and represent Avania on study conference calls and meetings. This position requires approximately 25-30% travel.

Requirements

Monitoring of medical device and MedTech studies.
Ensuring the highest ethical and clinical standards.
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 conducted as needed and tasks are 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.
Assisting Clinical Research Associates with difficult or challenging situations or corrective actions.
Conducting co-visits and providing feedback.
Reviewing monitoring reports.

Responsibilities

Supervise project-specific monitoring activities.
Coordinate project-specific training.
Interact with clients.
Act as the primary contact for study questions from the monitoring team.
Organize team training and study updates.
Generate necessary monitoring tools.
Ensure monitoring visits are conducted as needed and tasks are completed in an appropriate and timely manner.
Complete peer review of required study documentation to ensure accuracy, completeness, and high quality.
Represent Avania on study conference calls and/or meetings.
Collaborate with the Project Manager to ensure study objectives are met.
Handle CRA study activities as needed.
Provide CRA support, including assisting CRAs with difficult situations or corrective actions, conducting co-visits and providing feedback, and reviewing monitoring reports.