Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
 

How you’ll make an impact:

• The Senior Specialist, Clinical Patient Screening (Heart Failure) role will ensure trial patient safety by assuring compliance with clinical protocols through screening of medical history for early feasibility and pivotal trials in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with EW procedures and ethical standards.
• Conduct reviews and document medical narratives based upon screening/baseline source information to facilitate case reviews in accordance with regulatory requirements, trial safety processes, and EW procedures.
• Develop and maintain site relationships by performing all site communication correspondences.
• Resolve requests from sites and cross functional team members to expedite screening process and reduce protocol deviations/repeat assessments.
• Assess screening/baseline source documents 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 data for accuracy, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
• Educate and provide training to enrolling sites to ensure protocol requirements are followed and to facilitate enrollment.
• Provide guidance and direction to lower level staff.

What you'll need (Required):

• Bachelor's of Science in Nursing degree (BSN) or equivalent with 5 years of experience working with heart failure patients in a clinical setting required OR
• Master's of Science Degree: Nurse Practitioner or Physician Assistant or equivalent with 3 years experience working with heart failure patients in a clinical setting required.

What else we look for (Preferred):

• Experience working in the setting of a clinical trial preferred
• Excellent problem-solving, organizational, analytical skills.
• Familiarity with reading and interpreting invasive waveforms such as pulmonary artery pressures, pulmonary vascular resistance, and cardiac output.
• Interpretation of diagnostic tests such as coronary angiogram, pulmonary function tests, endoscopy/colonoscopy reports etc.
• Good understanding of CT parameters
• Proficiency in evaluation of pertinent lab values such as complete blood count, liver function tests, renal function, and familiarity with normal values.
• Strong foundation in pharmacology and medical treatment of cardiovascular disease.
• Experience with an electronic data capturing system (e.g iMedidata), image transfer systems (e.g BioClinica) and CTMS (Clinical Trial Management System) preferred.
• Working knowledge of the principals of clinical research including Good Clinical Practice (GCP).
• Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies skills including consultative and relationship management skills.
• Excellent problem-solving and critical thinking skills.
• Moderate understanding of pre-clinical testing protocols, hospital environments and sterile techniques.
• Moderate understanding of biostatistics including principals of trial design, study hypothesis, and importance of clinical trial endpoints.
• Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.

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.

Aligning 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.

For California, the base pay range for this position is $103,000 to $146,000 (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.