Clinical Research Associate

3 weeks ago

Columbus, Ohio, United States Edwards Lifesciences Full time
Transform Patient Lives with Edwards Lifesciences

Imagine how your expertise can change a patient's life. At Edwards Lifesciences, 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.

Drive Evidence for Patient Outcomes

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. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs.

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.
  • 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.
  • Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
  • 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.
  • Edit/amend informed consent documents.
  • Other incidental duties.
Requirements
  • Bachelor's Degree or equivalent in related field.
  • 1 year experience field monitoring experience, quality assurance/control and regulatory compliance OR 1 year 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, preferred.
  • Ability to travel up to 75% for clinical site visits.
  • Covid Vaccination.
Preferred Qualifications
  • Substantial computer literacy in MS Office, to include Word, Excel, Adobe and ability to operate general computer software and office machinery.
  • Understanding of cardiovascular anatomy, pathology and physiology.
  • 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 with electronic data capture.

Edwards Lifesciences is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards Lifesciences is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.

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