Field Clinical Research Monitor, USA, Southeast, Endotronix

Edwards Lifesciences is growing and our

Field

Clinical Research Monitor, USA, Southeast, Endotronix

position is a unique career opportunity that could be your next step towards an exciting future. This role will sit within the Endotronix team, who develop implantable heart monitoring technology. Endotronix was acquired by Edwards in July 2024, and will support our future work with heart failure management solutions to address large unmet structural heart patient needs and support sustainable long-term growth.

For more details on the acquisition, please visit:

https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-port

How you will make an impact:

Ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.

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.

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 Committees, Clinical Operations (e.g. Contracts), and recommend and develop process improvements.

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.

Develop and deliver 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.

Contribute to the development of clinical protocols, informed consent forms, and case report forms.

Edit/amend informed consent documents.

Other incidental duties

What you'll need (Required):

Bachelor's Degree or Equivalent in related field, 3 years experience Field monitoring experience, quality assurance/control and regulatory compliance Required or

Experience working in a medical device or regulated industry Required or

Experience with electronic data capture Required

What else we look for (Preferred):

Additional Skills:

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

Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery

Demonstrated problem-solving and critical thinking skills

Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise

Substantial 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

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.

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

COVID Vaccination Requirement

Edwards 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.