Address
Form of work
SalaryShockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Description
Position Overview
The Principal Clinical Research Associate (CRA) is responsible for the day-to-day management of a global clinical study. The Principal CRA will be accountable for project management activities, oversight of multiple vendors and for conducting a global clinical study in compliance with applicable clinical and regulatory standards and in alignment with the business needs. The individual is a subject matter expert in Clinical Research and this work is accomplished with minimal oversight, requires frequent contact with internal and external customers and is critical to the success of the business.
Essential Job Functions
- Responsible for organizing, communicating and evaluating team objectives for clinical studies
- Participates in study design and study preparation activities
- Development of clinical trial documentation including clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions
- Participates or leads the process to evaluate and select potential investigators and sites
- Participates or leads the process to evaluate and select potential vendors as applicable
- Conducts or oversees site visits as required (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct
- Develops site training tools, interprets clinical data, manages investigational sites, develops tracking tools and performs other clinical activities as needed during clinical study conduct
- Leads clinical study teams focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies.
- Manages project timelines and vendor performance to meet departmental and corporate goals
- Monitors and tracks clinical trial progress and provides status update reports
- Manages study budget, payment process and reconciliation of invoices for all clinical trial vendors including investigative sites when applicable
- Oversees work produced by junior clinical team members
- Manages all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG)
- Analyzes and evaluates clinical data gathered during research
- Leads, prepares and reviews project and study-related documents including: informed consent forms, investigational brochures, case report forms, monitoring plans, synopses, protocols and amendments, and other appropriate sections for studies conducted under Investigational Device Exemption (IDE) or 510(k) application.
- Responsible for authoring internal documents, clinical study reports or clinical evaluation reports
- Develops and revises annual, interim, and final reports and clinical sections of Pre- or Post-Market Approval submissions
- Coordinates the design, format and content of CRFs, study guides, study reference binders, and forms including participating in the EDC and IVRS specification process and UAT
- Coordinates and manages Investigational Product including overall accountability and reconciliation
- Responsible for selection of CRO study staff and coordinating training including documentation
- Leads the review of clinical data at the CRF, data listing, and report table levels
- Represents Clinical Affairs at the Project Team level for individual studies, as appropriate
- Identifies and escalates site, vendor and study related issues to supervisor, as appropriate
- Oversees clinical and adverse event data evaluation during the conduct of the study and for completion of clinical study reports. Working knowledge of CEC and DSMBs.
- Manages training of investigators, site staff, and SWMI clinical staff.
- Oversees quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions.
- Other duties as assigned.
Requirements
- Bachelor’s Degree or equivalent experience in a scientific field of study
- Minimum 10 years’ experience directly supporting Clinical Research or relevant experience in medical/scientific area. Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred.
- Ability to travel 10-20% domestically and internationally
- Thorough knowledge of Good Clinical Practice (GCP) is required
- Working knowledge of GCP, FDA, ISO and other applicable regulations
- Experience with EDC Data Management Systems
- Basic understanding of peripheral and coronary artery disease and therapies preferred
- Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running IDE trials
- ACRP or SOCRA Clinical Research certification preferred
- Able to manage multiple project teams
- Ability to work in a fast-paced environment while managing multiple priorities
- Operate as a team and/or independently while demonstrating flexibility to changing requirements
- Must have excellent verbal and written communication skills
- High attention to detail and accuracy
Market Range: $102,000 - $151,000
Exact compensation may vary based on skills, experience, and location.
Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:
Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance
Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer
