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Clinical Quality Associate Jobs (NOW HIRING)

Catalent Pharma Solutions in Kansas City, MO is hiring Associate II, Quality Assurance The Kansas City Clinical and Specialty Services (CSS) Quality Associate II supports clinical trial projects ...

The Quality Associate II/III provides routine technical support for various tasks (i.e ... clinical studies, stability studies, ETPs, and Regulatory submissions. QA III Primary ...

The Quality Associate II/III provides routine technical support for various tasks (i.e ... clinical studies, stability studies, ETPs, and Regulatory submissions. QA III Primary ...

Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during ... Clinical Quality Associate Director (CQAD). * Ensures timely collection/uploading of essential ...

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Clinical Quality Associate information

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$12

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$55

How much do clinical quality associate jobs pay per hour?

As of Jul 6, 2026, the average hourly pay for clinical quality associate in the United States is $31.54, according to ZipRecruiter salary data. Most workers in this role earn between $21.15 and $41.59 per hour, depending on experience, location, and employer.

How much does a clinical research associate get paid?

A clinical research associate (CRA) typically earns between $60,000 and $110,000 annually, depending on experience, location, and the complexity of trials. Entry-level CRAs may start around $60,000, while experienced professionals with specialized skills can earn over $100,000. Salaries often include benefits and may increase with certifications such as CCRP or RAC.

What is the difference between Clinical Quality Associate vs Clinical Research Coordinator?

AspectClinical Quality AssociateClinical Research Coordinator
Required CredentialsTypically a bachelor's degree in life sciences or related field; certifications like CQA are a plusBachelor's degree in health sciences, biology, or related field; often requires research-specific certifications
Work EnvironmentQuality assurance departments, regulatory compliance teams, pharmaceutical or biotech companiesClinical trial sites, hospitals, research institutions
Employer & Industry UsageUsed in pharmaceutical, biotech, and healthcare industries focusing on quality and complianceCommon in academic, hospital, and clinical research settings

The Clinical Quality Associate primarily focuses on ensuring compliance with quality standards and regulatory requirements within the industry, while the Clinical Research Coordinator manages the day-to-day operations of clinical trials. Both roles require strong attention to detail and knowledge of clinical processes but differ in their core responsibilities and work environments.

What does clinical QA do?

A Clinical Quality Associate (QA) monitors and ensures compliance with clinical trial protocols, regulatory standards, and Good Clinical Practice (GCP) guidelines. They review data, audit processes, and document findings to maintain the quality and integrity of clinical research. Strong attention to detail and knowledge of regulatory requirements are essential for this role.

Is CRA an entry level job?

A Clinical Research Associate (CRA) is typically not an entry-level position; it usually requires prior experience in clinical research, such as coordinating trials or working in healthcare. Entry-level roles in clinical research may include Clinical Trial Assistant or Clinical Research Coordinator, with CRAs often needing a background in life sciences and relevant certifications like SOCRA or ACRP. However, some companies offer trainee or junior CRA positions for candidates with limited experience who demonstrate strong organizational and communication skills.

What is the job of a clinical associate?

A clinical quality associate is responsible for monitoring and improving the quality and compliance of clinical trials and healthcare processes. They review data, ensure adherence to regulatory standards, and support the implementation of quality improvement initiatives, often using tools like electronic data capture systems. Strong attention to detail and knowledge of clinical regulations are essential for this role.

What are the main challenges Clinical Quality Associates face when ensuring compliance across multiple clinical trial sites?

Clinical Quality Associates often encounter the challenge of maintaining consistent quality and regulatory compliance across diverse clinical trial sites, each with their own procedures and personnel. Coordinating with site staff, monitoring documentation, and ensuring adherence to Good Clinical Practice (GCP) guidelines require strong communication and organizational skills. Additionally, adapting to frequent regulatory updates and handling discrepancies in real time can be demanding, but these challenges also offer opportunities to develop expertise in quality assurance processes and regulatory requirements.

What are the key skills and qualifications needed to thrive as a Clinical Quality Associate, and why are they important?

To thrive as a Clinical Quality Associate, you need a solid understanding of clinical research processes, regulatory compliance, and quality assurance principles, typically supported by a degree in life sciences or a related field. Familiarity with Good Clinical Practice (GCP) guidelines, clinical trial management systems (CTMS), and quality management software is often required. Strong attention to detail, analytical thinking, and effective communication skills make candidates stand out in this role. These skills ensure clinical trials adhere to regulatory standards and deliver reliable, high-quality data for patient safety and successful study outcomes.

What are Clinical Quality Associates?

Clinical Quality Associates are professionals who support the quality assurance processes within clinical trials or healthcare settings. They are responsible for ensuring that clinical practices comply with regulatory requirements, internal protocols, and industry standards. Their duties often include auditing clinical documents, monitoring study processes, and identifying areas for improvement. By maintaining high-quality standards, Clinical Quality Associates help ensure patient safety and the integrity of clinical data.
What cities are hiring for Clinical Quality Associate jobs? Cities with the most Clinical Quality Associate job openings:
What are the most commonly searched types of Clinical Quality jobs? The most popular types of Clinical Quality jobs are:
What states have the most Clinical Quality Associate jobs? States with the most job openings for Clinical Quality Associate jobs include:
Associate Director, Clinical Quality

Associate Director, Clinical Quality

Denali Therapeutics

South San Francisco, CA • On-site

$193K - $224K/yr

Full-time

Medical, Retirement

Posted 9 days ago


Job description

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
The Associate Director, GCP Clinical Quality will play a key role in ensuring the successful execution of Denali's clinical trials by delivering strategic quality oversight and fostering a culture of compliance and continuous improvement. This position partners cross-functionally across study teams, site leadership, and external partners to uphold high standards of GCP compliance, support inspection readiness, and contribute to the advancement of Denali's portfolio. The ideal candidate brings a proactive, solution-oriented approach to identifying quality risks, implementing corrective actions, and driving operational excellence across Clinical Development activities.
Key Accountabilities/Core Job Responsibilities:
  • Serve as a GCP Quality team member on Study Execution Teams (SETs) and deliver a cohesive strategic GCP framework across Denali clinical trials.
  • Partner with the Zurich Site Lead and cross-functional leaders to drive site growth, operational excellence, and portfolio advancement.
  • Monitor, analyze, and report on quality issues; provide strategic, risk-based guidance in line with GCP regulations and industry standards.
  • Identify quality and compliance gaps, recommend solutions, and support CAPA development and root cause analysis.
  • Participate in the evaluation, selection, and oversight of CROs and clinical vendors to ensure quality standards are met.
  • Foster collaboration across internal teams and external partners to maintain systems and processes aligned with regulatory requirements.
  • Support inspection readiness activities, including preparation for regulatory agency inspections, audits, and vendor assessments.
  • Contribute to the design, implementation, and continuous improvement of GCP Quality Systems, SOPs, and the overall Quality Management System (QMS).
  • Perform QA reviews of essential clinical trial documents and assist in the implementation of internal GCP QA processes and tools.
  • Represent Clinical Quality Assurance (CQA) in internal initiatives, champion a culture of compliance, ethics, and patient safety, and ensure GCP adherence across clinical programs.

Qualifications/Skills
  • Bachelor's Degree and 7+ years experience, with 6+ working in GCP QA .
  • Early phase study support experience desirable.
  • Working knowledge of ICH E6 GCP guidelines, FDA Code of Federal Regulations, and other global applicable laws and regulations
  • Experience applying risk-based methodology and working within the QMS framework
  • Knowledge of clinical trial systems and processes
  • Attention to detail and accuracy in work, while delivering on deadline
  • Excellent verbal, written communication, and interpersonal skills
  • Work according to procedures, guidelines and regulations
  • Critical thinker with ability to synthesize information from multiple sources and apply to problem-solving
  • Positive, self-starter and thrives under pressure
  • Able to work across multiple projects and prioritize tasks as required

Salary Range: $193,638.00 to $224,270.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.