Source Writer (Quality Assurance)

Arizona Liver Health; Chandler (AZ); Hybrid; USD 50,000 - 70,000; Full time

Benefits offered by this job

Health, Dental, Vision with HSA plans

401K with 6% company match

Educational Assistance

Short & Long Term Disability

Shared company vehicles

Job summary

A leading health research institute is seeking an experienced Source Writer with QA/QC/Regulatory expertise. You will ensure high standards of scientific excellence while contributing to transformative liver health initiatives. Responsibilities include generating source documents, performing QA reviews, and ensuring compliance with clinical research regulations. The ideal candidate will have a relevant degree and experience in clinical research. Competitive salary and benefits offered including health insurance, 401K match, and educational assistance.

Qualifications

• Proven knowledge of SOPs and GCPs.
• Basic knowledge of medical terminology.
• Experience in clinical research quality assurance and compliance.

Responsibilities

• Extract information from clinical research protocols.
• Ensure source documents are complete and accurate.
• Perform QA reviews of subject charts.

Skills

Critical thinking

Independence

Understanding clinical research protocols

Experience in building clinical research documents

Education

Associate or Bachelor's degree in healthcare or related field

Job description

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, Tucson, AZ, or Remote-US in preferred locations

This role is not open to hire in California, Colorado, New York, New Jersey, Oregon, or Massachusetts. 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.

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
• None

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)
• 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

EEO statement

It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.

Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and pushy inquiries may also be blocked across our network as spam. Thank you for your understanding and cooperation.