Clinical Research Associate

Job Description

Company Description :

Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures.

Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory.

These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information.

Core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere.

For more information, please visit www.stereotaxis.com.

Note : This position can be remote if candidate lives outside of St. Louis and is an in-office position at Stereotaxis HQ for local candidates.

Position Summary :

The Clinical Research Associate (CRA) is responsible for assisting in the day-to-day activities associated with the execution and monitoring of high-quality clinical trials.

The CRA ensures that clinical tasks are being performed in compliance with applicable regulatory standards, the principles of good clinical practice, and company policies and procedures.

Essential Responsibilities :

• Assist in the planning and execution of global clinical studies ensuring that deliverables are completed on time and within budget
• Create reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, and payments
• Assist with the development and management of study-related documents and materials
• Participate in the site qualification and initiation processes, including review of site documentation
• Conduct training of investigators and coordinators
• Coordinate, conduct, and report on monitoring visits to ensure compliance to the protocol and study plans and regulations, including source document verification, device accountability
• Verify appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements.

May write narratives and follow-up on serious adverse events

• Evaluate investigative sites to ensure sponsor support of trial activities and site compliance
• Assist with the development and implementation of site corrective actions as needed
• Assist with vendor management to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work

Job Requirements

Qualifications & Skills :

• BA / BS in engineering, life sciences, health sciences, nursing, medical technology, or equivalent
• 2+ years’ experience supporting medical device clinical research
• Strong working knowledge of good clinical practices, FDA regulations, ISO 14155, and current industry practices related to the conduct of clinical trials
• Ability to communicate clearly and concisely, detail oriented, strong organizational skills, responsive, independently driven
• Previous experience with EDC systems preferred
• Legally authorized to work in the United States

Work Conditions :

This role can be an in-office position at Stereotaxis’ headquarters or remote. This role should be able to travel 20% on average and up to 50% during peak periods local and internationally.

Culture :

Stereotaxis values steadfast integrity, intellectual excellence, responsiveness and reliability, and a dedication to constant improvement.

We take pride in the positive impact of our work and in building a collaborative and innovative work environment that embraces challenge.