Hiring company: Edwards Lifesciences
This is a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease. This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting edge technology.
The Transcatheter Heart Valve (THV) team extends Edwards’s leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis.
The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.
The Senior Clinical Research Monitor will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.
Key Responsibilities:
- Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
- Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Act as a mentor to new or junior level employees.
- Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics
- Committees/Research Ethics Boards, Contract, and Training, developing process improvements.
- Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
- Validate investigational device accountability by tracking the history of investigational devices from
Edwards to the field sites and through final disposition.
- Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
Edit/amend informed consent documents.
Education and Experience:
- Bachelor's Degree and 5 years of previous field monitoring experience required or Associate's Degree and 7 years of previous field monitoring experience.
- Quality assurance/control and regulatory compliance Required
- Other: Experience working in a medical device or regulated industry Preferred
- Other: Experience with electronic data capture Preferred
Additional Skills:
- Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
- Demonstrated problem-solving and critical thinking skill
- Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
- Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
- Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
- Technical writing skills (protocols, CRF development, study tools)
- Ability to communicate and relate well with key opinion leaders and clinical personnel
Experience in training new hires
For Colorado Residents Only:
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
The base pay range for this position is $114,000to$133,000
Additional information can be found through the link below:
https://www.edwards.com/careers/benefits
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.