New · posted Nov 1
Edwards Lifesciences · Medical Devices
Senior Specialist, Clinical Research Monitoring
- Remote, US
- Remote
- Full-time
- Senior & Principal
The role
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.
We’re dedicated to pioneering next-generation innovations for patients with aortic regurgitation (AR). Our Transcatheter Heart Valve (THV) business unit brings together Clinical Affairs, Engineering, and Research professionals to design and develop minimally invasive therapies that impact patient outcomes and quality of life. We’re working together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease. Join us and be part of our inspiring journey.
What you need
What you’ll need (Required)
- Bachelor's Degree or equivalent in related field with 5 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria.
- Ability to travel up to 75% domestically.
What else we look for (Preferred)nice to have
- Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification.
- Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills.
- Demonstrated problem-solving and critical thinking skills.
- Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery.
- Excellent understanding of cardiovascular anatomy, pathology, and physiology or Business Unit area of expertise.
- Moderate 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 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 $108,000 to $153,000 (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.
What you'll do
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.
- Developing and delivering 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. Acting as a mentor to new or junior level employees.
- 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 Boards, Contract, and Training, developing process improvements.
- Contributing to the development of clinical protocols, informed consent forms, and case report forms.
- Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
- 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.
- Editing/amending informed consent documents.
Pay and benefits
$108,000 – $153,000 a year
Employer providedCompetitive salary
Performance-based incentives
Wide variety of benefits programs for employees and families
Equal opportunity, accessibility and legal noticesEdwards Lifesciences's statements, word for word
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% above the US median for Clinical Research roles at this level.
This roleEmployer provided
Senior & Principal roles in the US50 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $108,000 | — | $153,000 |
| All US (middle half) | $123,750 | $124,500 | $130,500 |
This role: Edwards Lifesciences's own published range. Comparisons: the base pay employers published on open Clinical Research roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Research
The general path across 193 open Clinical Research roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.
Career resources on Clinical Research
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct9
- Documentation and SOPs7
- Collaboration and leadership6
- GMP and compliance5
- Investigations and CAPA4
- Lab testing and methods1
- Validation and qualification1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Edwards Lifesciences on Regulatory Jobs
- 31
- Open roles
- 30
- Distinct roles
- 6
- Locations
By discipline
- Quality18 58%
- Regulatory7 23%
- Clinical6 19%
By level
- Senior & Principal20 65%
- Associate & Specialist6 19%
- Director3 10%
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Senior Specialist, Clinical Research Monitoring at Edwards Lifesciences
Open until filled. $108K–$153K a year, employer provided.