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Rep, Clinical Records
1442 Alton Parkway Irvine, CA 92606 US
Job Description
Target PR Range: 18-28/hr
*Depending on experience
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
Skills: Ability to Work with Others Detail oriented Team Player
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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