Edwards Lifesciences ยท 1 month ago
Senior Specialist, Clinical Research Monitoring THV (Mountain, Central US)
USA - Texas - Dallas
Full-time
Onsite
Senior Level
5+ years expEdwards Lifesciences is a company dedicated to improving patient outcomes through innovative medical technologies. The Senior Specialist in Clinical Research Monitoring will be responsible for field monitoring of clinical trials, ensuring data consistency and compliance with regulatory requirements, while also mentoring junior staff and contributing to the development of clinical protocols.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
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
Qualification
Required
Bachelor's Degree and a minimum of 5 years of work experience in clinical research monitoring, with a strong focus on quality assurance, quality control, and regulatory compliance or equivalent based on Edwards criteria
Experience working in a regulated industry
Experience with electronic data capture
Ability to travel up to 75% for clinical site visits
Preferred
Knowledge of cardiovascular physiology and structural heart anatomy
Previous medical device Clinical Research experience in cardiology
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)
Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
2026-01-07
Orange County Business Journal
2026-01-04
BioWorld Financial Watch
2025-12-25
Company data provided by crunchbase