Clinical Research Monitor - San Francisco, United States - Edwards Lifesciences

Edwards Lifesciences

Verified Company

San Francisco, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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 impacts millions of people globally, yet it often remains under-diagnosed and undertreated.

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.

How you will make an impact:

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.
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.
Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
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.
Contribute to the development of clinical protocols, informed consent forms, and case report forms.
Edit/amend informed consent documents.
Other incidental duties

What you'll need (required):

Bachelor's Degree or Equivalent in Life Sciences or Nursing

3 years experience in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance or field monitoring

Experience working in a medical device or regulated industry

Experience with electronic data capture

Ability to travel up to 75% for clinical site visits

Covid Vaccination

What else we look for (preferred):

Strong written and verbal communication skills, presentation skills, interpersonal relationship skills, and analytical skills are required
Proven expertise in MS Office Suite and clinical systems, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
Demonstrated problemsolving and critical thinking skills
Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
Substantial 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
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