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Clinical Research Specialist, (Hybrid, Irvine)- Tmtt
Company | Edwards Lifesciences |
Address | Irvine, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing |
Expires | 2023-07-23 |
Posted at | 10 months ago |
Clinical Research Specialist, (Hybrid, Irvine)- Transcatheter Mitral & Tricuspid Therapies (TMTT)
- Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
- Other incidental duties
- 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
- 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
- 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
- Bachelor's Degree, required
- Ability to travel up to 10% for conferences and site monitor visits, required
- Covid vaccination, required
- 3 years of previous experience with regulatory documentation for clinical studies, required
- Data management experience or analytics
- Experience in cardiac clinical research
- Experience in Medical device trial
- Experience in site monitoring/central monitoring skills, site qualification, and site training
- Sponsor industry experience with clinical trial operations/research
- Solid understanding of regulatory submissions, reporting, and audits
- Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
- 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
- Ability to manage confidential information with discretion
- Ability to manage competing priorities in a fast paced environment
- Ability to build productive internal/external working relationships
- Solid knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
- Ability to interact professionally with all organizational levels
- Excellent written and verbal communication skills and interpersonal relationship skills
- Excellent problem-solving and critical thinking skills
- 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
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