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Rep, Clinical Operations

Irvine, CA 92614

Posted: 01/27/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 530432 Is job remote?: No Country: United States

Job Description

Duties
Responsible for efficient processing and quality check of all study documents.

Key Responsibilities:
• Conduct periodic audits of documentation and may participate in internal master file audits
• Provide support for Clinical Core Labs team
• Participate in site outreach to retrieve missing imaging
• Compile image tracking and status reports
• Archive documents including emails from sites and core labs, group procedures, group meetings
• Provide basic troubleshooting assistance (e.g. enroll new users, generate reports from online learning management system, etc.
• Provide administrative support for Clinical Core Labs group
• Other incidental duties 

 
Skills
Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with RAVE EDC and Veeva preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Ability to work in a fast paced environment
• Substantial knowledge and understanding of Clients policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
• Good problem-solving skills
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Must be able to work in a team environment under minimal supervision
• No instructions needed on routine work, and general instructions given only on new lines of work or special assignments
• 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


Education/Experience
H.S. Diploma or equivalent 2 years experience. Related experience Required Bachelor's Degree Preferred

23-28 pay rate range
**salary will be commensurate with experience**
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