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Ardelyx, Inc. · 1 day ago

Clinical Records Specialist I

Newark, CA

Full-time

Onsite

Entry Level

$74K/yr - $90K/yr

1+ years exp

Ardelyx, Inc. is a biopharmaceutical company focused on developing innovative medicines. They are seeking a Clinical Records Specialist I to perform quality reviews and manage trial-related records in compliance with regulatory standards and company procedures.

BiotechnologyHealth CareMedical

Comp. & Benefits

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

Qualification

TMF records experienceGCP/ICH standardsGDP guidelinesMS Office proficiencyETMF system experienceCommunication skillsOrganizational skillsAttention to detailWork independently

Required

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)

Preferred

Smartsheet experience is a plus

Benefits

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

At least 11 paid holidays

Company

Ardelyx, Inc.

Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.

Founded in 2007

Fremont, California, USA

201-500 employees