What are the responsibilities and job description for the Medical Review Specialist, Clinical Patient Screening (Heart Failure), Irvine, Ca Based position at Edwards Lifesciences LLC?
This is an exciting opportunity for you to join a team boldly designing transcatheter mitral and tricuspid therapies from the ground up. Edwards’ Transcatheter Mitral and Tricuspid Therapies team is deeply dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives around the world.
The Medical Review Specialist Clinical Patient Screening will be responsible for the management of screening workflows for early feasibility and pivotal studies. This position is based in Irvine, Ca.
Key Responsibilities:
- Assess for and screen-out patients according to exclusion criteria by reviewing source documents received from the investigational sites or from the electronic database
- Evaluate medical records by applying clinical protocol knowledge
- Analyze screening information (e.g., medical records, right heart hemodynamics, labs, EKG) to ensure
- compliance with inclusion criteria
- Provide medical insight and guidance to team members
- Query sites for additional information to ensure clinical protocol requirements are met
- Conduct site trainings, educate clinical staff regarding medical guidance for trial qualification
- Other duties as assigned by management
Education and Experience:
- Bachelor’s Degree in Nursing with 3 years of previous related medical experience, Or equivalent medical certifications and/or medical degree with 3 years of previous related experience.
- Other: Physician Assistant, Nurse Practitioner (e.g., Mid-level Practitioner) with 3 years of related experience.
- Experience working with heart failure patients in a clinical setting required
- Experience working in the setting of a clinical trial preferred
Additional Skills:
- Proven successful project management skills
- Proven expertise in MS Office Suite
- Excellent written and verbal communication skills and interpersonal relationships requiring diplomacy and influence
- Excellent problem-solving, organizational, analytical skills
- 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 medical terminology as it relates to clinical patient screening
- 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
