Senior Clinical Research Monitor - Edwards Lifesciences : Job Details

Join to apply for the Senior Clinical Research Monitor role at Edwards Lifesciences1 day ago Be among the first 25 applicantsJoin to apply for the Senior Clinical Research Monitor role at Edwards LifesciencesGet AI-powered advice on this job and more exclusive features.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.Aortic Stenosis and Aortic Regurgitation impact millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.We are searching for a Senior Clinical Research Monitor to join Edwards Aortic Regurgitation Field Monitoring team. As a Senior Clinical Research Monitor, you ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.How you'll make an impact: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.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.Edit/amend informed consent documents.What you'll need (Required):Bachelor's Degree in related field or equivalent5 years of work experience in clinical research monitoring, with a strong focus on quality assurance, quality control, and regulatory complianceExperience working in a regulated industryExperience with electronic data captureAbility to travel up to 75% for clinical site visitsCovid VaccinationWhat else we look for (Preferred):Knowledge of cardiovascular physiology and structural heart anatomyPrevious medical device Clinical Research experience in cardiologyClinical 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 requiredProven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer softwareAdditional skills:Demonstrated problem-solving and critical thinking skillsExcellent understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertiseModerate understanding of medical device regulatory requirements and documents, device accountability and adverse events reportingTechnical writing skills (protocols, CRF development, study tools)Ability to communicate and relate well with key opinion leaders and clinical personnelAligning 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.The base pay range for this position is $106,000 to $140,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.Seniority level Seniority level Not ApplicableEmployment type Employment type Full-timeJob function Job function OtherIndustries Medical Equipment ManufacturingReferrals increase your chances of interviewing at Edwards Lifesciences by 2xSign in to set job alerts for “Monitor” roles. 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