Note: The job is a remote job and is open to candidates in USA. Shockwave Medical is a part of Johnson & Johnson, a leader in healthcare innovation. The Sr. Field Clinical Engineer will develop and execute recruitment strategies for clinical trials while providing case support for Shockwave Medical products, ensuring effective training and data collection at clinical sites.
Responsibilities
- Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices
- Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms
- Provide clinical and technical support for key study investigators and clinical leaders at assigned sites
- Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues
- Administrative activities including training to procedures at site level
- Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals
- Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools
- Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked
- Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals
- Partner with assigned physician advisors to create and deliver recruitment strategies
- Partner with vendors that support recruitment activities
- Other duties as assigned
Skills
- Bachelor's Degree in a scientific field of study or equivalent work experience
- Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional or surgical procedures within a hospital
- Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials
- Thorough knowledge of Good Clinical Practice (GCP) is required
- Ability to attain and maintain hospital credentials
- 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
- Experience with electronic data capture (EDC) systems
- Must have excellent verbal and written communication skills
- High attention to detail and accuracy
- Able to manage multiple project teams with guidance
- Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.)
- Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America
- May be required to lift up to 25 pounds
- Analytical Reasoning
- Business Behavior
- Clinical Operations
- Clinical Research and Regulations
- Clinical Trial Designs
- Coaching
- Communication
- Ethical and Participant Safety Considerations
- Innovation
- Laboratory Operations
- Office Administration
- Preclinical Research
- Problem Solving
- Project Management
- Project Schedule
- Research and Development
- Study Management
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Company Overview