What are the responsibilities and job description for the Clinical Research Associate - Remote position at Talascend?
Talascend is hiring a Clinical Research Associate (100% Remote, long-term contract) to support a leading medical technology and diagnostics company. Competitive pay and benefits provided.
OVERVIEW :
The Ultrasound segment is the global leader in ultrasound medical devices and solutions, spanning the continuum of care to support screening, diagnosis, treatment, and monitoring of diseases. Our goal is to improve efficiency in radiology and beyond, enhancing user confidence to achieve better clinical outcomes. As a result, the demand for AI, digital solutions, and automation is growing, connecting devices and software into a seamless ecosystem.
The Caption Health SBU focuses on using AI in clinical applications to assist in early disease detection through ultrasound scans. Caption Health is currently seeking a Clinical Research Associate (CRA) with medical device experience. The CRA will be responsible for supporting medical device clinical trials (software as a medical device) through site monitoring to ensure patient well-being, verify accurate study data, and maintain protocol compliance.
PRIMARY RESPONSIBILITIES :
- Serve as the primary contact between the research site and the company for monitoring activities in multiple clinical trials, ensuring compliance with Good Clinical Practices, ISO 14155, and other regulations.
- Verify data accuracy by comparing Case Report Forms with source documents, review informed consent forms, and ensure regulatory documents and device accountability records are accurate.
- Provide clear written communication to clinical sites and project team members via monitoring reports, study memos, follow-up letters, and general correspondence.
- Ensure site personnel are properly trained to conduct the clinical study according to the protocol and applicable regulations. Maintain personnel qualification and training records.
- Address protocol deviations by documenting, communicating, and escalating as necessary through monitoring visits, study metrics analysis, and data review.
- Ensure all reportable events are identified, documented, and reported according to protocol and regulations.
- Attend internal and external meetings as needed to support discussion and decisions related to monitoring strategy, study, regulatory, or GCP requirements.
- Develop Study Monitoring Plans, Monitoring Visit Reports (SQV, SIV, IMV, COV), follow-up letters, and Risk Assessments.
- Contribute to the review and maintenance of QMS work instructions governing Study Monitoring and identify areas for improvement.
POSITION REQUIREMENTS :
DESIRED QUALIFICATIONS :
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Salary : $95
