Clinical Research Specialist, (Irvine)- Thv

Clinical Research Specialist, (In-house, Irvine) - Transcatheter Heart Valve (THV)

Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease. The Clinical Research Specialist, will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements. This position is located at our Irvine headquarters, there will be at least four days working in the office.

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
• Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
• 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
• Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
• Other incidental duties

Minimum Education and Experience:

• 3 years of previous experience with regulatory documentation for clinical studies, required
• Bachelor's Degree, required
• Ability to travel up to 10% for conferences and site meetings, required
• Covid vaccination, required

Preferred Qualifications- in addition to meeting minimum requirements, it would be nice to have the following:

• Experience in cardiac clinical research
• Experience in clinical site monitoring, site qualification, and site educational training
• Sponsor industry experience with clinical trial operations/research
• Experience in Medical device trial

Additional 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
• Strict attention to detail
• Excellent problem-solving and critical thinking skills
• Ability to manage competing priorities in a fast paced environment
• Ability to manage confidential information with discretion
• 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
• Solid knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
• Solid understanding of regulatory submissions, reporting, and audits
• Ability to build productive internal/external working relationships
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Excellent written and verbal communication skills and interpersonal relationship skills
• Ability to interact professionally with all organizational levels

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 California, the base pay range for this position is $81,000 to $114,000(highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.