Clinical Operations Coordinator Jobs

Position Details:

Role: Sr Rep, Clinical Operations

Location: REMOTE

Duration:18+ Month Assignment (possibility of extension)

: Summary:

The main function of a clinical operations representative is to be 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

•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

•May be required to work in the coordinator role as dictated by business needs

•Monitor device inventory by coordinating with Supply Chain and Clinical Specialists

•Other incidental duties (e.g. occasional photo copying or deliveries)

Additional Skills:

•Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery

•Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred

•Good written and verbal communication skills and interpersonal relationship skills

•Ability to work in a fast paced environment

•Substantial knowledge and understanding of 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 and Experience:

•H.S. Diploma or equivalent

•5-7 years of experience