- QCs trial records according to Good Documentation Practices (GDP), applicable US and international regulations/guidelines including ALCOA and ALCOA+ principles and company WI and procedures.
- Maintains and manages Ardelyx's electronic and paper Trial Master Files (TMF) in an inspection readiness state.
- Applies proper classification and metadata to essential records per the TMF Plan, TMF Index and company WIs.
- Documents, tracks and works alongside internal/external team members to resolve quality issues/findings.
- Performs eTMF/TMF archivals, transfers and migrations, as needed.
- Supports the development, management and maintenance of Clinical systems (e.g., eTMF, eISF, CTMS, etc.).
- Provides regular trial records status metrics/updates to internal and external stakeholders.
- Generates and distributes study-specific meetings minutes, as required.
- Participates in the review and updating of department plans, SOPs and WIs, as required.
- Prepares trial documentation, including Investigator Site File binders, as required.
- Bachelor's degree or equivalent experience.
- 2-3 years of direct experience working with TMF records.
- Experience with the TMF Reference Model, GCP and GDP standards and applicable Regulatory requirements.
- Knowledge and experience with clinical and operational issues involved with clinical research.
- Recognition and understanding of clinical research documents, their contents and purpose.
- Excellent organizational skills, follow-through, and attention to detail.
- Must be able to follow SOPs and WIs and effectively triage when deviations from procedures occur.
- 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).
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Clinical Records Specialist - Fremont, United States - Ardelyx, Inc.
Description
Ardelyx was 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), as well as early-stage pipeline candidates.
Job Description:
Lots of biotech companies say they are unique. At Ardelyx, Inc, we believe we truly are.
With an ethos of constant learning, belief in each other, and trusted to spread our wings beyond what's expected, we have not forgotten why we're here-to work closely with patients, the medical community, and each other, to deliver innovative medicines that matter.
Our successes have enabled our team to experience the full range of drug development-from the development of our in-house scientific platform, which has enabled pioneering insights into new biological mechanisms, to the discovery and development of first-in-class therapies that exploit those mechanisms, through to regulatory approval.
We are seeking a Clinical trial professional with excellent attention to detail and communication/organizational skills to assist with the management of trial related records based on applicable US (and international, if applicable) regulations and guidelines as well as company Work Instructions, and procedures.
Responsibilities and Duties:
The Clinical Records Specialist responsibilities and duties include but are not limited to:
Position Requirements:
The anticipated annualized base pay range for this full-time position is $57,298 - $70,030. 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 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.
