Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.We are searching for a Clinical Research Monitor to join Edwards Tricuspid team based in the Midwest region. As the Clinical Research Monitor, you will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence. The ideal candidate will reside in Midwest/ Northeast region.How you'll make an impact:
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.
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 Committees, Clinical Operations (e.g. Contracts), and recommend and develop process improvements.
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.
Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
Develop and deliver 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.
Contribute to the development of clinical protocols, informed consent forms, and case report forms.
Edit/amend informed consent documents.
Other incidental duties
What you'll need (Required):
Bachelor's Degree or equivalent in Life Sciences or Nursing
3 year's relative work experience in the areas of clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance or field monitoring
Experience working in a medical device or regulated industry
Experience with electronic data capture
Ability to travel up to 75% for clinical site visits
Covid Vaccination
What else we look for (Preferred):
Strong written and verbal communication skills, presentation skills, interpersonal relationship skills, and analytical skills
Understanding of cardiovascular anatomy, pathology and physiology
Experience with Cardiovascular device trials or structural heart clinical research knowledge
Proven expertise in MS Office Suite and clinical systems, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
Demonstrated problem-solving and critical thinking skills
Substantial 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
