Clinical Research Associate

Role Summary

We are seeking a passionate and detail-oriented Clinical Research Associate to join the Pathware team to help improve lung cancer care through our novel technology that aims to provide clinicians rapid feedback to guide biopsies. This is a remote position requiring approximately 80% travel to hospital and clinical sites across the country. In this vital role, you will represent our company at the point of care, guiding the implementation of our technology and protocols to validate its performance and support research goals. You will work together with clinicians and hospital staff to conduct research, validate system performance, and gather crucial data to support our product's intended use claims and support our submission for FDA clearance. If you are a self-starter passionate about advancing healthcare technology through hands-on clinical research, this is the perfect opportunity for you.

Pathware’s technology is limited to investigational use only. It has not been cleared by the U.S. Food and Drug Administration (FDA) and is not commercially available in the United States.

Key Responsibilities

Clinical Site Management & Monitoring: Serve as the clinical representative for research sites. You'll be responsible for site initiation, relationship management, and study support in clinical procedures to ensure compliance with protocols and regulatory standards.

Data Collection & Integrity: Oversee the collection of high-quality clinical data. This includes performing clinical data verification, ensuring accurate case reporting, and maintaining organized clinical investigation files.

Technical Deployment & Training: Lead the on-site deployment and implementation of our medical device technology. You will provide comprehensive training and ongoing support to physicians, nurses, research coordinators, and other clinical staff to ensure proper system use and protocol adherence.

Cross-Functional Collaboration: Act as a critical liaison between clinical sites and our internal teams. You will gather user feedback and clinical insights, coordinating directly with the Product and Engineering departments to drive product improvements and development.

Research & Protocol Development: Assist in the development of clinical research strategies, study protocols, and other investigation-related documentation. You'll contribute to an evidence-based approach to validate system performance and support device claims.

Next Generation Product Development: Assist in identifying and executing data collection and research into new product features and indications for use. Explore future opportunities to expand the technology, such as use for additional tissue types and human factors improvements.

Qualifications & Skills

Required:

Bachelor's degree in a life science, biology, biomedical engineering, or a related field.

Minimum of 2-3 years of experience in a clinical role (e.g., Clinical Research Coordinator, Clinical Research Associate, Clinical Representative, Clinical Applications Specialist, etc.).

Demonstrated ability to work independently and manage time effectively in a remote environment.

Applicants must be legally authorized to work in the United States on a full-time basis without the need for employer-sponsored visa.

Willingness and ability to travel up to 80%, both regionally and nationally.

Exceptional interpersonal and communication skills, with a proven ability to build strong relationships with clinicians and hospital staff.

Strong organizational skills and meticulous attention to detail.

Technical aptitude and comfort with learning and troubleshooting new technology.

Preferred:

Previous experience with medical device trials is highly desirable.

Hands-on experience with Good Clinical Practice (GCP) guidelines and FDA regulations.

Prior experience in pathology, cytology, pulmonology procedures, and/or endoscopy procedures.

Experience working in a fast-paced startup environment.