New · posted Nov 10
Edwards Lifesciences · Medical Devices
Senior Specialist, Clinical Research Monitoring
- Remote, California, 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.
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).
- Experience in clinical trials of medical devices.
- Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills.
- Experience in clinical trials of medical devices.
- Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification).
- 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.
- 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'll 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.
- 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 salaries
Performance-based incentives
Wide variety of benefits programs
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 10, 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 California14 roles publishing pay
Senior & Principal roles in the US63 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $108,000 | — | $153,000 |
| California (middle half) | $124,500 | $124,500 | $129,000 |
| All US (middle half) | $113,500 | $124,500 | $126,750 |
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 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Research
The general path across 243 open Clinical Research roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct11
- Documentation and SOPs6
- 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, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Research work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigationsNamed in the posting
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
From Regulatory News
Company hiring pulse
Edwards Lifesciences on Regulatory Jobs
- 31
- Open roles
- 31
- Distinct roles
- 7
- Locations
By discipline
- Quality18 58%
- Clinical7 23%
- Regulatory6 19%
By level
- Senior & Principal21 68%
- Associate & Specialist5 16%
- Director3 10%
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Senior Specialist, Clinical Research Monitoring at Edwards Lifesciences
Open until filled. $108K–$153K a year, employer provided.