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 Senior Specialist, Clinical Research Associate - Remote will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements with a responsibility of field site co-monitoring of up to 50%.
Essential Job Functions/Key Responsibilities:
- Responsible for study start-up and study conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing sites. Communicating the status of study progress and co-monitoring activities.
- Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution. Oversee the work of the Sr Representative and may provide coaching and training to lower level employees
- Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
- Lead in assessing current and new processes, identifying opportunities and implementing solutions to improve process efficiency within and across related functional areas
- Conduct in-house and site (if applicable) reviews of associated documentation and lead in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure documents are compliant with Good Documentation Practices and Edwards internal SOPs, and US and OUS regulations
- Partner with clinical project manager in leading regular team meetings
- Prepare materials for steering and investigator meetings
- Bachelor's degree and 5 years of experience within regulatory documentation for clinical studies
- Certifications with ACRP or SOCRA preferred
- Mentoring other Junior CRA's experience preferred
- Co-monitoring CRA visits experience preferred
- FDA audit experience preferred
- Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
- Excellent written and verbal communication skills and interpersonal relationship skills
- Excellent problem-solving and critical thinking skills
- Full knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
- Full 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 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 EHS rules and requirements 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
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.