Clinical Records Specialist

United States·Newarkmid

OtherClinical

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Quick Summary

Overview

Key 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…

Requirements Summary

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…

Technical Tools

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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:

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

The anticipated annualized base pay range for this full-time position is $74,000-$90,000. 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.