Clinical Operations Specialist Jobs

We have an exciting opportunity for a Clinical Operations Representative position with one of the top medical device companies in the country. This position will efficiently process and quality check of all study documents.

Responsibilities:

• Conduct periodic audits of documentation and may participate in internal master file audits
• May be required to work in the coordinator role as dictated by business needs
• Other incidental duties (e.g. occasional photo copying or deliveries).
• Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
• Review and ensure accuracy and completeness of clinical study files and/or device accountability logs, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials

Skills and Experience:

• Good problem-solving skills
• Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Substantial knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
• 5-7 years of experience
• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
• H.S. Diploma or equivalent
• Strict attention to detail
• Must be able to work in a team environment under minimal supervision
• Ability to manage confidential information with discretion
• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Ability to work in a fast paced environment
• No instructions needed on routine work, and general instructions given only on new lines of work or special assignments
• Ability to interact professionally with all organizational levels

Compensation:

• $22.60 to $30.13 per hour.