Respicardia, ZOLLMED.com
At ZOLL, we're passionate about improving patient outcomes and helping save lives.
We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Respicardia division of ZOLL Medical Corporation is focused on helping people with central sleep apnea get access to a therapy to restore a more normal breathing pattern during sleep and give them better quality of life. We develop breakthrough therapies for an impactful disease that is severely underdiagnosed and often untreated.
As we continue to grow, those who join our team will work alongside motivated people who care about others, put patients first and are dedicated to high-quality and innovative solutions.
Job TypeHybrid
Job SummaryThis position works independently and proactively to coordinate all necessary activities required for setting up and monitoring a study, completing accurate study status reports, project management, data management, and maintaining study documentation. The position may be involved in the submission of a protocol consent documents for ethics/IRB approval, site initiation and close out, device accountability and assist in the preparation of regulatory submissions as requested.
Essential Functions- Create and update the monitoring plan for clinical studies as applicable
- Track monitoring schedules and needs for site visits based on the clinical investigational plan and the monitoring plan
- Review monitoring reports
- Train monitors on the clinical investigational plan, the monitoring plan and applicable SOPs
- Ensure adherence by clinical sites and internal staff of all applicable regulations and standards
- Monitor clinical sites
- Assist in writing protocols, informed consent documents, contract amendments, clinical study reports, regulatory reports or committee reports as needed
- Understand and maintain a strong working knowledge of EDC system and the ability to ensure quality, accurate data through query resolution
- Show investigational device accountability
- Liaison with clinical sites, CRO and other outside vendors/core labs as needed
Required/Preferred Education and Experience- Bachelor's Degree in life science, nursing or an equivalent
- Experience with one or more EDC systems
- Experience with project management, training a plus
- Medical device experience with Class III Implantable Medical Devices
Knowledge, Skills and Abilities- Knowledge of ICH GCP guidelines and the expertise to review and evaluate medical data
- Possess excellent written and verbal communication and interpersonal skills
- Ability to produce accurate work to tight deadlines
- Proficient in Microsoft Office applications, including Word, PowerPoint and Excel
- Assist with the review and interpretation of clinical study data; writing, editing, compiling and quality controlling documents
- Ensure the accuracy and quality of applicable monitoring activities (site initiation, interim monitoring and study closeout visits)
- Compliance with ethical, legal scientific regulatory standards
- Excellent organization skills, attention to detail and a customer service demeanor
Travel Requirements- Ability to travel (including overnight stays) 50%
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.