Spec, Clinical Research

7 months ago

North Ryde, Australia Edwards Lifesciences Full time

Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. An exciting opportunity has arisen to join our dedicated and passionate Clinical Affairs team based in North Ryde.

**Job Function**:
Reporting to the Senior Director for Clinical Affairs, you will be responsible for supporting the implementation of assigned clinical research projects related to specific products/topics according to internal and external regional requirements. This will include the acquisition of human use approval from Ethics Committees, case report form review, data collection, site monitoring and auditing. You will maintain close contact with the clinical study site coordinators and physicians who are clinical investigators.

**Key Responsibilities**:

- Serve as the key contact to assigned clinical sites throughout the study process
- Develop new improved processes and perform implementation
- Document procedural case observations for insights in investigating post procedural events
- Identify and report adverse events and device-related complications in accordance with regulatory and internal requirements
- Support the study team in the interactions with Ethics Committees and Competent Authorities
- Participate actively to project team meetings with accountability for achieving and reporting on agreed clinical milestones and close collaboration with internal stakeholders to ensure proper project conduct
- Ensure Audit readiness for internal, external and site Audits
- Data review, safety reporting and complaint handling
- Provide site and Edwards personnel training including preparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required
- Report site enrolment progress including device accountability and enrolment deviations (inclusion/exclusion criteria, sequential enrolment)
- Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation.

**Education and Experience**:
Bachelor's Degree in a related field

3+ Years experience in medical devices and /or clinical experience required.

Previous experience in a CRA role

Previous cardiovascular experience highly regarded.

**Additional Skills**:
Ability to travel - frequent travel throughout ANZ - up to 40% of time

Excellent communication and organizational skills

Proven expertise in MS Office Suite and ability to operate general office machinery

Good written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills

Good problem-solving and critical thinking skills

In return, you will be rewarded with a competitive salary package and the opportunity to join a fantastic culture that truly puts patients first while appreciating that our people are our priority. If you are driven and passionate and want to be a part of leading innovation, we would love to hear from you today.

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 18,500 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

**For United States Applicants Only**:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

**Know your Rights**: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

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