Specialist, Clinical Research Monitoring, reputed company Coast US

reputed company how your reputed company 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 reputed company patients’ lives. As part of our Clinical Affairs team, you’ll reputed company your scientific curiosity and passion for evaluating data to increase reputed company to pioneering technologies for patients in need. In reputed company partnership with reputed company investigators, dedicated medical professionals, patient advocacy reputed company, and regulatory authorities, you will drive the evidence needed to optimize patient reputed company.

Many structural heart patients suffer from heart failure with limited reputed company. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic reputed company. Our reputed company are not just transforming patient care but also creating a unique and exciting environment for reputed company members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring reputed company.

How you will reputed company an reputed company:

• Field monitoring of studies and data collection for clinical trials, assess reputed company data documentation, reports, records, transcripts, exam results for consistency with case report reputed company, and determine if clinical trial/study subject documentation is reputed company parameters of study hypothesis, as reputed company as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
• reputed company reputed company of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data reputed company) to reputed company investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. reputed company), and recommend and reputed company process improvements
• Verify trial/study data, including maintaining appropriate regulatory documents both reputed company, auditing to be reputed company the site has the appropriate regulatory documentation to conduct the trial/study, and reputed company 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
• reputed company and deliver training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as reputed company as training and proctoring new employees on trial and study reputed company activities
• Contribute to the development of clinical protocols, informed consent forms, and case report forms
• Edit/amend informed consent documents

You will need (Required):

• Bachelor's Degree
• A minimum of 3 years field monitoring experience or site-level study coordination experience
• Experience working in a medical device or regulated industry
• Experience with electronic data capture
• Ability to travel up to 80%

What else we look for (Preferred):

• Demonstrated problem-solving and critical thinking skills
• Strong understanding of cardiovascular anatomy, pathology and physiology
• Substantial understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Technical writing skills (protocols, CRF development, study tools)

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide reputed company of benefits programs to address the diverse individual needs of our employees and their families.

For California, the reputed company pay reputed company for this position is $85,000 to $120,000 (highly reputed company). 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 reputed company employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the reputed company providers who are treating them. As such, reputed company patient-facing and in-hospital positions require COVID-19 vaccination. If reputed company into a covered role, as a condition of employment, you will be required to submit reputed company that you have been vaccinated for COVID-19, unless you request and are reputed company 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.

Originally posted on Himalayas

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