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 an Associate Clinical Research Monitor to join Edwards Transcatheter Mitral and Tricuspid Therapies team based in the Western region. As an Associate Clinical Research Monitor, you ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.How you will 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.
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.
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/Clinical Operations (e.g. Contracts), and recommend and develop process improvements.
Develop and deliver training on GCPs, protocols, and database, compliance, device accountability, and adverse event reporting.
Edit/amend informed consent documents.
What you'll need (Required):
Bachelor's Degree or equivalent in related field
1 year experience field monitoring experience, quality assurance/control and regulatory compliance OR
Experience working in an environment with hands-on clinical research experience encompassing all aspects of the clinical process, including 1) Cardiovascular device trials; and 2) Cath lab, operating room and/or intensive care unit familiarity, preferred
What else we look for (Preferred):
Ability to travel up to 50% to clinical sites
Good written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
Substantial computer literacy in MS Office, to include Word, Excel, Adobe and ability to operate general computer software and office machinery
Good problem-solving and critical thinking skills
Understanding of cardiovascular anatomy, pathology and physiology
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 with electronic data capture preferred
Good written and verbal communication skills and interpersonal relationship skills
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 $66,000 to $93,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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 Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.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.
