PQ Bypass is growing and we’re growing fast. Based in the heart of Silicon Valley, we’re developing technologies designed to change how long-segment lower limb peripheral arterial disease is treated.
We work hard, we have fun and – most importantly – we’re making a difference.
If this sounds like the kind of place you’d like to come to every day, please drop us a line at the email below.
Clinical Research Associate
This position is responsible for supporting the operational management of implantable cardiovascular clinical trials (US and OUS) and performing all associated operations from start to finish, consistent with applicable regulations, guidelines, and policies. This position should be able to independently handle various clinical trial assignments.
• Responsible for monitoring the conduct of clinical trials.
• Collaborate with RA-CA manager for the successful development and timely execution of clinical trials and projects.
• Manage relationships with site personnel (Investigator/ Coordinator) vital to the success of clinical trials.
• Provides input into the preparation of clinical trial documentation (e.g. protocol, ICF, CRF forms, databases, trackers, budgets and other clinical trial tools and documents) in consultation with the cross-functional project team.
• Prepare and submits (when appropriate) IRB submissions.
• Conduct site initiation and monitoring activities.
• Monitor trial site(s) progress against goals in order to achieve clinical targets.
• Participate in the development of a comprehensive system for data acquisition, storage and analysis from multiple clinical trials.
• Assist with data entry, as required, review of clinical data/information and provides oversight of data correction.
• Participate in the clinical department SOP review and development.
• Recruit, hire, train, manage and develop staff as required.
• All other duties as assigned.
• Excellent communication skills; including written, verbal and presentation.
• Excellent organizational skills and attention to details.
• Comfortable working in a hospital setting (Cath. Lab and/or O.R.).
• Strong data analysis skills.
• Action oriented and motivated by results.
• Comfortable with ambiguity.
• Exemplifies integrity and strong values.
• Leads and influences constituents with possible divergent interests to complete a common goal.
• Proficient in computer skills (Microsoft Office products, word processing, excel, etc.).
• Minimum ten years of experience in clinical research.
• Bachelor’s Degree in technical, scientific or health-related field or ten years’ experience.
While performing the duties of this job, the employee is frequently required to stand, walk, and sit. Employee must be able to lift 25 pounds.