Clinical Research Monitoring (Remote, Midwest/Northeast) Tmtt

Clinical Research Monitoring (Remote, Midwest/Northeast) 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 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.
Key Responsibilities:

• 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.
• 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.
• Contribute to the development of clinical protocols, informed consent forms, and case report forms.
• Other incidental duties
• 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.
• 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.
• Edit/amend informed consent documents.

Minimum Education and Experience:

• Ability to travel 75% to clinical sites
• Bachelor's Degree in related field, required
• Covid Vaccination, required
• Experience with electronic data capture, preferred
• Experience working in a medical device or regulated industry, preferred
• 3 years of previous clinical research field monitoring experience OR, quality assurance/control and regulatory compliance experience, required

Additional Skills:

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

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