Clinical Research Monitor, Midwest

2 months ago

Missouri, United States Edwards Lifesciences Corp Full time

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.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

As the Clinical Research Monitor on the Aortic team, you will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.

How you'll make an impact:

* Field monitor 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 years experience in 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 are required


* 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


* Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise


* 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


* Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control



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.

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