Job Description

Description

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).

This will be a contract to permanent opportunity located at our Newark CA office.

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

Qualifications:

• Bachelors 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

The anticipated annualized base pay range for this full-time position is $74000-$90000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees including a 401(k) plan with generous employer match 12 weeks of paid parental leave up to 12 weeks of living organ and bone marrow leave equity incentive plans health plans (medical prescription drug dental and vision)life insurance and disability flexible time off annual Winter Holiday shut down and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.

Required Experience:

IC

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