Position Title: Rep, Clinical Records
Work Location: Irvine, CA 92606
Assignment Duration: 9 Months
Work Arrangement: Onsite

Position Summary:
The main function of a clinical records representative is to ensure accuracy and completeness of documents for clinical studies.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
• 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

Qualification & Experience:

• 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 The Organization policies and procedures relevant to clinical study documentation
• Basic knowledge of EW GDP (Good Document Practice) 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 & Experience

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

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 25.00/hr.