About Heartflow

Job Responsibilities

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks.
• Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans.
• Participates in and leads process improvement activities within the department and cross functionally, including SOP development.
• Conducts study start-up activities including leading study kick off meetings, contract management, and site onboarding and training.
• Reviews site regulatory documents as needed to ensure compliance with study requirements and GCPs.
• Maintains effective working relationships with investigators, site research coordinators, and vendors including core labs and data management.
• Tracks internal and external project deliverables to ensure they remain within timeline and budget.
• Performs other duties as required for successfully completing studies.

Skills Needed

• Ability to work in a smaller team environment with a willing, all hands-on deck attitude.
• Ability to manage multiple tasks and be comfortable in an environment with shifting priorities.
• High attention to detail, accuracy, and quality with ability to effectively prioritize multiple projects.
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations.
• Excellent written and oral English communication skills.
• Proficiency in Microsoft Office programs including Word, Excel, and PowerPoint.

Educational Requirements & Work Experience

• Bachelor's degree in science or health related field.
• Minimum 5 years relevant experience required.
• Experience managing investigator initiated studies is a plus.
• Experience in cardiovascular medical device clinical research is a plus.

Additional Information