Jobs and Careers
AR
Clinical Records Specialist I
ArdelyxUnited Statesfull_timeVerifiedPosted 9 Jan 2026
💰 $90,000/yr($74,000/yr – $90,000/yr)
About the role
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. We are seeking a Clinical Records Specialist I with excellent attention to detail and communication/organizational skills to assist in the quality review, tracking and processing of trial related records based on applicable Good Clinical Practice (GCP)/International Council for Harmonsition of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulations, Good Documentation Practice (GDP) guidelines, as well as company Standard Operations Procedures (SOPs) and Work Instructions (WIs). Responsibilities:
- Conduct quality reviews on trial records according to applicable GCP/ICH regulations and GDP guidelines including ALCOA and ALCOA+ principles and company SOPs and WIs
- Apply proper classification and metadata to essential records per the study TMF Plan, and index
- Generate, track and work alongside internal/external stake holders on quality issues/findings
- Support the receipt and shipment of physical trial records to/from long term offsite storage
- Complete the updates of study specific trackers, including the TMF index, when needed
- Identify, communicate, and follow up on trial record deficiencies
- Bachelor’s degree with 1+ years of direct experience working with TMF records or equivalent research/pharmaceutical experience
- Experience with the TMF Reference Model, GCP/ICH and GDP standards and applicable regulatory requirements
- Excellent organizational skills, follow-through, and attention to detail
- Excellent oral and written communication skills
- Ability to work independently on routine assignments or under supervision on new assignments
- Quality and timelines focused
- Proficient in MS Office products (e.g. Excel, Power Point & Word) and eTMF system (e.g., Veeva, Medidata, Phlex)
- Smartsheet experience is a plus
- Note: Technical assessment will be administered for top candidates
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s