Spec, Clinical Research

Support implementation of assigned clinical research projects related to specific products/topics according to internal and external regional requirements, including acquisition of human use approval from Ethics Committees, case report form review, data collection, site monitoring and auditing. Maintain close contact with clinical study site coordinators and physicians who are clinical investigators.

**Key Responsibilities**:

- Serve as 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
- Supports 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
- Ensures 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 enrollment progress including device accountability and enrollment deviations (inclusion/exclusion criteria, sequential enrollment)
- Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation.
- Other incidental duties

**Education and Experience**:
Bachelor's Degree in related field, 3 Years years experience previous related medical device and /or clinical experience Required

**Additional Skills**:

- 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
- 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

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 13,000 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.
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