Senior Specialist, Clinical Patient Screening Heart Failure TMTT

$103,000 - $146,000/Yr

Edwards Lifesciences

Full-time - Mid Level

10,001+ employees

Miscellaneous Manufacturing

About the position

The Senior Specialist, Clinical Patient Screening (Heart Failure) role is focused on ensuring patient safety during clinical trials by verifying compliance with clinical protocols. This position involves screening medical histories for early feasibility and pivotal trials, conducting reviews, and documenting medical narratives. The role also emphasizes developing site relationships, resolving requests to expedite the screening process, and educating enrolling sites on protocol requirements.

Responsibilities

• Ensure trial patient safety by assuring compliance with clinical protocols through screening of medical history.
• Conduct reviews and document medical narratives based on screening/baseline source information.
• Develop and maintain site relationships through effective communication.
• Resolve requests from sites and cross-functional team members to expedite the screening process.
• Assess screening/baseline source documents for consistency with case report forms.
• Monitor data for accuracy in accordance with protocols and regulatory requirements.
• Educate and provide training to enrolling sites to ensure protocol adherence.
• Provide guidance and direction to lower-level staff.

Requirements

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

Nice-to-haves

• Experience working in the setting of a clinical trial.
• Excellent problem-solving, organizational, and analytical skills.
• Familiarity with reading and interpreting invasive waveforms such as pulmonary artery pressures and cardiac output.
• Interpretation of diagnostic tests such as coronary angiograms and pulmonary function tests.
• Good understanding of CT parameters and evaluation of pertinent lab values.
• Strong foundation in pharmacology and medical treatment of cardiovascular disease.
• Experience with electronic data capturing systems and clinical trial management systems.
• Working knowledge of clinical research principles including Good Clinical Practice (GCP).
• Moderate understanding of pre-clinical testing protocols and hospital environments.

Benefits

• Competitive salaries
• Performance-based incentives
• Wide variety of benefits programs to address diverse individual needs