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. As the Senior Clinical Research Monitor, you will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.
You will make an impact by...
* 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.
* Other incidental duties
What you'll need (Required):
* Bachelor's Degree in related field or equivalent
* 5 years of medical device/sponsor/CRO/Pharma clinical field monitoring experience, quality assurance/control and regulatory compliance
* 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):
* Knowledge of cardiovascular physiology and structural heart anatomy
* Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification)
* Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k)
* Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
* Experience in training new hires
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 $101,000 to $142,000 (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 Requirement
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 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.