Job Description
Job Description
Job Title: In-House Site Clinical Research Associate (Site CRA) – QA Oversight
Department: Clinical Operations / Quality Assurance
Reports To: Director of Clinical Operations / QA Manager
Location: Hybrid – Primarily Remote with Travel to Southern California Sites
Position Summary:
The In-House Site Clinical Research Associate (Site CRA) is responsible for internal quality oversight of clinical research activities across a network of sites. This role focuses on maintaining compliance, ensuring data integrity, and supporting site teams through proactive monitoring and internal audits. The Site CRA will primarily conduct remote QA and document review while performing on-site visits in Southern California for training, audits, and process verification. After eSource implementation, this role will transition primarily to remote oversight with limited travel.
Key Responsibilities:
Internal Quality Oversight
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Conduct remote QA reviews of source data, eSource entries, and regulatory binders for accuracy and compliance.
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Identify trends in protocol deviations, data entry errors, and missing documentation.
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Collaborate with site teams to implement corrective and preventive actions (CAPAs).
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Track and maintain internal QA metrics for site performance and study compliance.
On-Site Audits & Support
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Travel to Southern California sites for periodic internal audits and QA inspections.
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Verify that informed consent, protocol adherence, and safety reporting processes meet GCP standards.
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Support site teams in preparing for sponsor or regulatory audits.
Regulatory & Documentation Review
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Ensure all essential documents are complete, accurate, and maintained according to ICH/GCP standards.
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Review and verify that all deviations, SAEs, and protocol exceptions are documented appropriately.
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Assist with maintaining Investigator Site Files (ISF) and trial master documentation.
Training & Communication
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Provide feedback and training to site teams on compliance and quality findings.
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Act as an internal liaison between QA and site staff, escalating recurring issues to management.
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Participate in regular internal meetings to review QA trends and develop process improvements.
Travel & Remote Work
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Travel to Southern California sites is required for QA audits and site support.
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Majority of work will be conducted remotely, with travel decreasing as eSource and remote QA tools are fully implemented.
Qualifications:
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Bachelor’s degree in Life Sciences, Nursing, or related field required.
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1–3 years of experience in clinical research (CRC, CRA, or QA experience preferred).
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Strong knowledge of GCP, ICH guidelines, and FDA regulations.
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Experience in quality assurance or site compliance is highly desirable.
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Excellent attention to detail and ability to analyze and interpret data trends.
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Proficiency in Microsoft Office and electronic data management systems.
Preferred Skills:
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Experience with eSource systems and remote monitoring or QA processes.
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Familiarity with internal auditing and CAPA management.
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Strong organizational skills and effective communication with multi-site teams.
Benefits:
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Competitive salary and performance incentives.
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Health, dental insurance.
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Paid time off and holidays.
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Opportunities for career advancement in quality and clinical operations.
Company DescriptionKinetic Clinical Research is a boutique clinical research services provider based in Anaheim, California, operating multiple community-connected sites across SoCal
Company Description
Kinetic Clinical Research is a boutique clinical research services provider based in Anaheim, California, operating multiple community-connected sites across SoCal