Senior Clinical Research Monitor (Remote, East Coast Region), Transcatheter Mitral & Tricuspid Therapies (TMTT)

This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.

The Sr. Clinical Research Monitor will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence. The role will require up to 75% of travel on a regional basis to East Coast states.

Key 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.

Minimum Education and Experience:
Bachelor's Degree in related field, required

5 years' experience of previous field clinical research monitoring experience, required

Covid vaccination, required

Field monitoring experience, quality assurance/control and regulatory compliance, required

Preferred Qualifications- in addition to meeting minimum requirements, it would be nice to have the following:

Experience with structural heart therapeutic area, is a plus

Knowledge of cardiovascular physiology and structural heart anatomy is a strong preference

Experience working in a medical device industry or regulated industry, strongly preferred

Experience with electronic data capture, preferred

Additional Skills:

• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
• 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
• Strong 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
• 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

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 $101 000 to $142 000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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Disability accommodation for employment applicants
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Family and Medical Leave Act (FMLA)
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