Senior Clinical Research Monitor

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.

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As the Senior Clinical Research Monitor, you will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.

You will make an impact by...

• 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.

• Develop and deliver 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. Act as a mentor to new or junior level employees.

• 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 Boards, Contract, and Training, developing process improvements.

• Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.

• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition (as needed per protocol).

• 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.

• Review of informed consent and other source documentation for compliance

What you'll need (Required):

• Bachelor's Degree in related field or equivalent

• 5 years of medical device/sponsor/CRO/Pharma clinical study field monitoring experience, quality assurance/control and regulatory compliance

• Experience working in a medical device or regulated industry

• Risk management experience (ie. ability to support site compliance through diligent follow up and documentation of trends and issues)

• Experience with electronic data capture

• Ability to travel up to 75% for clinical site visits

• Covid Vaccination

What else we look for (Preferred):

• Experience with Risk-Based Monitoring

• Knowledge of cardiovascular physiology and structural heart anatomy

• Experience with Medidata CTMS, Medidata RAVE, Coupa, and Veeva Vault and other clinical data capturing systems

• Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification)

• Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k)

• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required.

• Demonstrated problem-solving, critical thinking skills, strict attention to detail

• 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 expertise

• Moderate understanding of medical device regulatory requirements and documents, device accountab