Source Writer (Quality Assurance)
About The Position
Arizona Liver Health (ALH) is seeking an experienced Source Writer with a background in QA/QC/Regulatory. As a key member of our team, you will play a crucial role in ensuring the highest standards of scientific excellence. ALH is at the forefront of transformative liver health initiatives and other disease treatments and therapies, dedicated to pioneering research, fostering innovation, and improving patient outcomes. As we embark on groundbreaking clinical trials and research endeavors, we recognize the critical importance of a skilled and knowledgeable workforce. The Source Writer will contribute to driving advancements in health outcomes.
Requirements
- 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)
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
Number of Employees
101-250 employees
