Job Information
Edwards Lifesciences In-House CRA in Naperville, Illinois
Edwards Lifesciences is growing and our In-House CRA, Endotronix position is a unique career opportunity that could be your next step towards an exciting future. This role will sit within the Endotronix team, who develop implantable heart monitoring technology. Endotronix was acquired by Edwards in July 2024, and will support our future work with heart failure management solutions to address large unmet structural heart patient needs and support sustainable long-term growth.
For more details on the acquisition, please visit: https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-port
Edwards Lifesciences Expands Structural Heart Portfolio With Acquisitions of JenaValve and Endotronix
IRVINE, Calif.--(BUSINESS WIRE)-- Edwards Lifesciences (NYSE: EW) today announced investments that reflect the company’s deep commitment to advancing patient care through structural heart innovation, addressing large unmet patient needs and supporting sustainable long-term growth. Edwards has entered into an agreement to acquire JenaValve Technology, a pioneer in the transcatheter treatment ...
www.edwards.com
How you will make an impact:
You will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements
Key Responsibilities:
Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities
Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations
Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
Other incidental duties
What you'll need (Required):
Bachelor's Degree or Equivalent in Life Sciences or Nursing, 3 years years experience in clinical research (site management, clinical project management, monitoring, and/or CRC) including quality assurance/control and regulatory compliance or field monitoring with experience in the healthcare industry Required and
Experience working in a medical device or regulated industry Preferred and
Experience in electronic data capture Required
What else we look for (Preferred):
Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
Strong written and verbal communication skills, presentation skills, interpersonal relationship skills, and analytical skills are required
Strong problem-solving and critical thinking skills
Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
Moderate understanding of regulatory submissions, reporting, and audits
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Ability to build productive internal/external working relationships
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 Illinois, the base pay range for this position is $85,000 to $120,000 (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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted 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.
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