Edwards Lifesciences
Specialist, Clinical Research Monitoring
Edwards Lifesciences, Saint Paul, Minnesota, United States
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 under-treated. 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.
How you will make an impact
Field monitoring of studies and data collection for clinical trials, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
Providing 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 recommending and developing process improvements.
Verifying 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.
Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
Developing and delivering 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.
Contributing to the development of clinical protocols, informed consent forms, and case report forms.
Editing/amending informed consent documents.
What you’ll need (Required)
Bachelor's Degree in related field with previous field monitoring experience, quality assurance/control and regulatory compliance required or equivalent work experience based on Edwards criteria.
Ability to travel up to 75% domestically.
What else we look for (Preferred)
Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification)
Strong written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills
Proven expertise in MS Office Suite, 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
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.
For California (CA), the base pay range for this position is $85,000 to $120,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
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Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. 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.
How you will make an impact
Field monitoring of studies and data collection for clinical trials, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
Providing 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 recommending and developing process improvements.
Verifying 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.
Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
Developing and delivering 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.
Contributing to the development of clinical protocols, informed consent forms, and case report forms.
Editing/amending informed consent documents.
What you’ll need (Required)
Bachelor's Degree in related field with previous field monitoring experience, quality assurance/control and regulatory compliance required or equivalent work experience based on Edwards criteria.
Ability to travel up to 75% domestically.
What else we look for (Preferred)
Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification)
Strong written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills
Proven expertise in MS Office Suite, 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
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.
For California (CA), the base pay range for this position is $85,000 to $120,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
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