Clinical Records Representative (TMF/CTMS) - Infosoft : Job Details

Job Title: Clinical Records Representative (TMF/CTMS)

Pay Rate: $31.52/HR

Duration: 12 months

Location: Irvine, CA (Onsite)

Shift timing - starts between 7 AM to 9 AM with 8 hours shift

Our Client is a Global medical device Manufacturer.

We are looking for a Clinical Records Representative (TMF/CTMS)

Summary:

The main function of a clinical records representative is to ensure the accuracy and completeness of documents for clinical studies.

Key Responsibilities:

• Review and ensure accuracy and completeness of clinical trials or study documents (e.g., EFS, pivotal) ensuring GDP and performing quality checks with limited supervision
• Organize and archive documents and data in eTMF (electronic trial master file) and/or CTMS (Clinical trial management system) ensuring compliance with internal procedures and regulatory guidelines
• Support team members during internal and external audits
• Other incidental duties: May maintain and track study supplies

Additional Skills:

• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Good written and verbal communication skills and interpersonal relationship skills
• Basic knowledge and understanding of our policies and procedures relevant to clinical study documentation
• Basic knowledge of GDP (Good Document Practice) and SOP requirements
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to manage competing priorities in a fast-paced environment
• Ability to interact professionally with all team organizational levels
• Must be able to work in a team environment, including inter-departmental teams
• Ability to Provide feedback in a professional, direct, and tactful manner

Education and Experience:

• H.S. Diploma or equivalent Required
• 2-4 years of experience