Associate Clinical Research Monitor (Remote) Thv

Associate Clinical Research Monitor (Remote)- Transcatheter Heart Valve (THV) ​
Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease. The Associate Clinical Research Monitor, will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence. This role will require up to 75% of travel.
Key Responsibilities:

• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
• Other incidental duties
• 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.
• Edit/amend informed consent documents.
• 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.
• 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/Clinical Operations (e.g. Contracts), and recommend and develop process improvements.
• Develop and deliver training on GCPs, protocols, and database, compliance, device accountability, and adverse event reporting.

Minimum Education and Experience:
Bachelor's Degree in Life Sciences or related field, required
1 year experience of previous field monitoring experience, required OR experience working in an environment with hands-on clinical research experience encompassing all aspects of the clinical process, including 1) Cardiovascular device trials; and 2) Cath lab, operating room and/or intensive care unit familiarity, required
Covid vaccination, required
Ability to travel up to 75% to clinical sites, required
Preferred but not required: Clinical research certification (ACRP or SoCRA)
Additional Skills:

• Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• 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
• Substantial computer literacy in MS Office, to include Word, Excel, Adobe and ability to operate general computer software and office machinery
• Good written and verbal communication skills and interpersonal relationship skills
• Technical writing skills (protocols, CRF development, study tools)
• Good computer skills in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
• Ability to communicate and relate well with key opinion leaders and clinical personnel
• Good problem-solving and critical thinking skills
• Experience with electronic data capture preferred
• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required

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 $64,000 to $91,000 (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 18,500 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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