What are the responsibilities and job description for the Research Quality and Assurance Specialist position at Azza HealthCare Agency?
This role requires expert judgment and decision-making in clinical research regulations and quality systems, with a focus on analyzing documentation, data verification, and managing CAPA follow-up with minimal oversight.
Responsibilities include providing guidance to enhance institutional research practices, developing training materials, and ensuring regulatory compliance to maintain research integrity and organizational risk management.
Qualifications include a minimum of three years of clinical research experience in monitoring, auditing, or QA/QC, with a preference for oncology or hematology research experience. A bachelor's degree in a related field is required, with RN credentials preferred.
Key skills involve thorough knowledge of ICH GCP, FDA CFR, HIPAA, IRB processes, and institutional SOPs. Familiarity with systems like Complion, Epic, REDCap, and NCI CTSU is advantageous. Certifications such as SOCRA or ACRP are preferred.
Responsibilities include providing guidance to enhance institutional research practices, developing training materials, and ensuring regulatory compliance to maintain research integrity and organizational risk management.
Qualifications include a minimum of three years of clinical research experience in monitoring, auditing, or QA/QC, with a preference for oncology or hematology research experience. A bachelor's degree in a related field is required, with RN credentials preferred.
Key skills involve thorough knowledge of ICH GCP, FDA CFR, HIPAA, IRB processes, and institutional SOPs. Familiarity with systems like Complion, Epic, REDCap, and NCI CTSU is advantageous. Certifications such as SOCRA or ACRP are preferred.