CLINICAL TRIAL ASSISTANT Second Sight Medical Products

Job Description: Responsible for providing administrative support to the Clinical Affairs and Regulatory Affairs departments with a focus on clinical compliance-related items. The main responsibilities include maintain records (i.e. record creation, data entry and filing) for clinical trial data, clinical trial device orders/returns/accountability and customer feedback and complaint handling. Essential Duties & Responsibilities: Handle all procedural, documentary and data entry aspects of clinical trial data. Prepare customer orders for clinical trial materials and returned goods authorizations. Maintain device accountability database by entering in records of shipments and returns. Answer queries related to device accountability. Issue device accountability reports to support monitoring of the study. Assist Clinical Affairs, Regulatory Affairs and Field Clinical Engineering personnel with administrative projects including copying, filing, data entry and other aspects of records management. Receive and process reports of customer feedback and complaints. Work with Regulatory Affairs, Quality Assurance and the Field Clinical Engineering teams throughout this process. Contribute to clinical in-house procedure development in areas of responsibility. Work within cross functional teams to provide assistance to meet the clinical and regulatory teams needs. Qualifications: Education: Bachelors Degree required, preferably in Engineering, Physical or Biological sciences. Experience: 1-2 years of experience in quality assurance, regulatory or clinical affairs or equivalent combination of education and experience. Required Knowledge & Skills/Abilities: Practical working knowledge of compliance, quality assurance, procedures and records. General understanding of clinical trials Excellent people skills and team oriented. Effective written and verbal communication skills Comfortable working in a fast-paced, dynamic work environment. Detail-oriented with strong organizational skills Computer skills with advanced working knowledge of Microsoft Word, Excel, Outlook and PowerPoint. Experience with Microsoft Access is a plus. Able and prepared to undertake additional tasks to assist in meeting immediate needs and the team and company goals.

Location:	Sylmar, CA United States