Clinical Records Representative

Company: Apex Systems
Location: Irvine
Posted on: September 15, 2023

Job Description:

Rep, Clinical Records

Irvine, CA

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
  
  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 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 and Experience:
    • H.S. Diploma or equivalent Required
    • 2-4 years of experience
      
      EEO Employer
      
      Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.
      
      Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing - in Talent Satisfaction in the United States and Great Place to Work - in the United Kingdom and Mexico.

Keywords: Apex Systems, Irvine , Clinical Records Representative, Healthcare , Irvine, California