Clinical Records Representative Jobs

Summary:

The main function of a Clinical Records Representative is to ensure accuracy and completeness of documents for clinical studies.

Job Title: Associate Clinical Records Representative

Duration: 1-year

Work Location: Irvine, CA - hybrid (subject to performance after 3 months)

Pay Rate: $25.44 - $26.51/hr

Apply if you have:

• Lab experience or an interest in biotechnologies, the clinical field, or healthcare.
• 0-2 years of administrative experience within healthcare or another scientific industry.
• Experience with eTMF or CTMS systems (e.g.,Veeva Vault)

Key Responsibilities:

• Review and ensure accuracy and completeness of clinical study documents (e.g., EFS, pivotal) ensuring GDP and performing quality checks with limited supervision
• Other incidental duties: May maintain and track study supplies
• 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

Additional Skills:

• Strict attention to detail
• Good written and verbal communication skills and interpersonal relationship skills
• Must be able to work in a team environment, including inter-departmental teams
• ETMF experience is a plus
• Exposure to Veeva Vault and CTMS is a plus
• Ability to manage competing priorities in a fast paced environment
• Basic knowledge and understanding of corproate policies and procedures relevant to clinical study documentation
• High School Diploma requried, Bachelor's Degree in a scientific study Preferred
• Ability to interact professionally with all team organizational levels
• Ability to manage confidential information with discretion
• Ability to Provide feedback in a professional, direct, and tactful manner
• Basic knowledge of GDP (Good Document Practice) and SOP requirements
• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery