Arizona Liver Health · 5 days ago
Source Writer (Quality Assurance)
United States
Full-time
Remote
Mid Level
$50K/yr - $70K/yrArizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials. The Source Writer will play a crucial role in ensuring the highest standards of scientific excellence and contribute to driving advancements in health outcomes.
Clinical TrialsHealth CareHospitalityMedical
Responsibilities
Extract information from clinical research protocols, consent forms, study manuals, and EDC guidelines to generate study specific source documents in electronic system
Ensure source documents are complete and accurate to ensure high quality data is collected
Ensure appropriate procedure logics are added to all source to alert for study related requirements
Perform QA reviews of subject charts
Perform other duties as assigned
Ensures procedures meet or exceed all relevant institutional, state, and federal requirements for the conduct of clinical research; and ensures clinical research activities are conducted, generated, documented, and reported in compliance with the protocol, Good Clinical Practice (GCP) guidelines, and all other applicable regulatory agencies
Qualification
Required
A thorough understanding of how to extract information from clinical research protocols and study related materials
Experience in building clinical research source documents (either paper or electronic)
Proven knowledge of SOPs, GCPs and local/international regulations
Knowledge of clinical trial process and data management, clinical operations, quality management, and systems applications to support operations
Ability to work independently
Ability to complete study source in a timely manner
High level of critical thinking
Associate or Bachelor's degree in healthcare, clinical research management, or related preferred
Experience and training in the conduct of clinical research and basic knowledge of medical terminology
Experience and training in the conduct of clinical research quality assurance, quality control, regulatory, and compliance
Benefits
Health, Dental, Vision (with HSA plans and employer contribution)
2 weeks PTO
5 days Sick Time
7 Company holidays + 2 Half-days
401K with 6% company match
Short & Long Term Disability
Educational Assistance
Shared company vehicles for required travel
Company
Arizona Liver Health
Arizona Liver Health provides specialized diagnostics, evaluation, treatment for patients with liver disease and other liver conditions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Anita Kohli
Physician, CEO
Michelle Jones
Sr. Vice President Commercial Operations | Clinical Trial Partnerships
Recent News
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