Clinical Data Associate

HeartFlow•San Francisco, CA

47d•$85,000 - $115,000•Hybrid

About The Position

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMapAnalysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare. Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 400,000 patients worldwide. The Clinical Data Associate (CDA) is responsible for the oversight and management of all clinical data activities for a variety of different clinical trials and data associated with these trials. The CDA will interact well with the Heartflow Clinical Research staff and collaborate effectively with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors to ensure clinical studies meet or exceed timelines and maintain high quality standards. The CDA will have demonstrated experience managing different kinds of data for clinical trials, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast-paced start-up culture.

Requirements

Ability to work in a smaller team environment with a willing, all hands-on deck attitude
Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
Flexibility and willingness to learn new techniques and procedures to ensure the successful completion of projects
Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
Excellent written and oral English communication skills required
Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel, and PowerPoint; SAS a plus; Python a plus
Bachelor's degree in science or health related field
Demonstrated 2-4 years minimum relevant experience required

Nice To Haves

Experience in cardiovascular medical device clinical research a plus
Experience in registry studies and investigator-initiated studies a plus

Responsibilities

Manages project deliverables to ensure they remain within the timeline and budget
Develops timelines for data management activities, enrollment projections, and creates/modifies/reviews instructional materials in support of trial execution, including project and data management plans
Oversees the development of any clinical database by the EDC/CRO vendor, and will manage the sponsor user acceptance testing of the clinical database
Upload cases and enter biometrics for assigned clinical studies, as required
Participates in and leads process improvement activities within the department and cross functionally, including SOP development
Works with other clinical research team members on study start-up activities including the development and review of case report forms, source document worksheets, training presentations, etc.
Examines and resolves data inconsistencies within specified timelines that may be urgent in nature
Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs, consultants, and CROs
Works in coordination with statisticians, programmer/analysts, clinical research team members, and other team members as required
Acts as point of contact for data management in all meetings relating to a study
Perform other duties as required for successfully completing studies, as necessary
Some travel may be required; may occasionally attend investigator meetings, or vendor visits/audits