Senior Clinical Trial Associate

The Senior Clinical Trial Associate should have an interest in clinical research, a sharp eye for detail, outstanding organizational skills, a professional demeanor for both internal and external interactions, strong editing and proofreading skills, excellent technical and computer skills, the ability to learn and be flexible, and excellent time-management skills to be able to effectively prioritize competing deadlines.

Job Responsibilities:

• Manage multiple Investigator Initiated Clinical studies, which may include collecting regulatory documents as necessary, assisting with the contracting process between parties, tracking study progress internally and externally, being the main point of contact for external study teams and also internally at HeartFlow, participating in project team meetings, tracking and maintaining all study related information in the central study database and also maintaining accurate and complete files on the clinical drive. Ensure all study files are current and accurate. In addition, collect and organize all ancillary study related data and send for processing internally at HeartFlow as applicable and in compliance with HIPPA privacy laws; provide results back to the study investigators as required.
• Site management activities for HeartFlow sponsored study sites, which may include helping with potential enrollment issues, answering protocol and EDC related questions, reviewing data to ensure consistency and accuracy, tracking study visit progress, tracking expected payments to be made to the site, maintaining accurate and complete regulatory documentation, provide ongoing training as necessary to new and existing study staff, and additional tasks as required.
• Conduct study start up activities, which includes reviewing informed consent forms for accuracy and completeness, collecting required regulatory documentation from the site, assisting with IRB submissions, building study binders and miscellaneous study materials, assisting with the contracting process between Sponsor and Study Site, and other tasks as required. Provide day-to-day clinical project support for other research projects, which may include filing and maintaining Clinical Trial Master Files (TMFs), reviewing documents for accuracy, reviewing monitoring reports for completeness and accuracy, developing and updating departmental SOPs as necessary, and documenting and distributing meeting minutes.
• Manage and track finances against study budgets in accordance with executed study contracts, as well as collect and track invoices from clinical sites, and liaise with the Finance department as necessary.
• Assist with the development of required Heartflow sponsored study tools and documents, which may include: the testing and development of Electronic Databases, the development of CRFs and Source Documents, the development of logs and forms to be used at study sites, and additional tasks as required.
• Perform other duties as needed.

Skills Needed:

• Excellent written and oral English skills
• Strong interpersonal skills
• Excellent organizational skills
• Strong attention to detail and excellent follow through on assigned tasks
• Ability, flexibility, and willingness to learn new things quickly with little direction and/or guidance
• Ability to work independently as well as part of a project team
• Strong analytical skills and problem solving abilities
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) as well as Google Applications
• Ability to interact professionally both internally and externally
• Self-starter with the ability to multi-task and prioritize appropriately under pressure
• Knowledge of ICH-GCP guidelines and FDA regulations preferred

Educational Requirements & Work Experience: 

• BA or BS degree in a science or related field
• 3+ years demonstrated experience in human clinical research trials, or equivalent

A reasonable estimate of the yearly base compensation range is $85,000 to $120,000 and cash bonus. #LI-Hybrid