Regulatory Specialist
HeartFlow- Full Time
- Junior (1 to 2 years)
Candidates should possess an Associate’s Degree (preferred Bachelor’s Degree or related degree) or equivalent combination of education and experience, an ECG certificate, and demonstrated knowledge of cardiovascular physiology and anatomy. They must have 1-2 years of experience in ECG Core Lab or working under GCP, GDPR, and data privacy regulations, along with experience working in a team environment and a collaborative work ethic. Strong computer competencies, including Google, Microsoft suite (including Excel), and database management, are also required.
The Cardiac Specialist I will perform interval duration and rate measurements on digital or paper ECGs according to established Standard Operating Procedures (SOPs), evaluate and place calipers on digital ECGs, utilize validated software to convert PNG images to XML files, assess waveforms for conversion accuracy, accurately calibrate scaling of PDF images, process cardiac data from continuous Holter recordings, extract time-point specific 12-Lead ECG extractions, export XMLs to the designated database, evaluate ECGs for safety/alert findings and provide notification, participate in the Quality Assurance program, and meet or exceed departmental productivity and quality metrics.
Generates clinical evidence for trials
Clario specializes in generating clinical evidence for medical research by utilizing a comprehensive technology platform. Their services support various types of clinical trials, including decentralized, hybrid, and site-based trials. Clario's approach combines nearly 50 years of experience with a vast network of facilities across nine countries, allowing them to conduct a significant number of clinical trials and regulatory approvals. What sets Clario apart from competitors is their extensive expertise and the ability to provide a wide range of endpoint technologies, which enhances the quality of evidence produced. The company's goal is to empower partners in the healthcare industry to improve patient outcomes through reliable and rich clinical data.