Source Writer (Quality Assurance)

 

About Us:

Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.

 

Role Summary 

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. 

Title: Source Writer (Quality Assurance)

Compensation: $50k - $70k, depending on experience and qualifications

Status: Full-time, Non-exempt

Location: Chandler, AZ or Remote-US in preferred locations
Preference will be given toward candidates currently located in US states that we are already set up to do business -- this includes Arizona, Texas, Tennessee, Florida, Ohio, and Minnesota).
This role is not open to hire in California, Colorado, New York, New Jersey, Oregon, or Massachusetts. 

Essential job functions/duties:

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.  

• 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 

Knowledge/Skills/Abilities 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 

Travel requirements:

• None, 100% Remote

Education, credentials, and/or trainings required:

• 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 and Time Off:

• 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