Senior Specialist, Clinical Research Monitoring

Edwards Lifesciences•Irvine, CA

2d•Onsite

About The Position

Imagine how your ideas and expertise can change a patient’s life. 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. 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. Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

Requirements

Bachelor's Degree or equivalent in related field with 5 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria.
Ability to travel up to 75% domestically and internationally.

Nice To Haves

Clinical research certification (ACRP or SoCRA clinical coordinator/CRA certification)
Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills
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
Excellent understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
Moderate 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

Responsibilities

Field monitoring of studies and data collection for clinical trials, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining 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.
Developing and delivering 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.
Acting as a mentor to new or junior level employees.
Providing 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.
Contributing to the development of clinical protocols, informed consent forms, and case report forms.
Also contributing to team projects.
Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
Verifying 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.
Editing/amending informed consent documents.