Hybrid Quality Assurance Specialist, Research Administration, FT, 9A-5:30P

Baptist Health is a not-for-profit healthcare organization providing comprehensive medical care and clinical research services. The Quality Assurance Specialist 2 supports quality standards in research administration by educating operations staff, facilitating SOP functions and training, identifying process improvements, and developing quality and education programs for clinical research personnel.

Responsibilities

• The MCI Quality Assurance Specialist 2 is responsible for ensuring that industry standards of quality, are being met and exceeded on an on-going basis
• The individual will be responsible for providing education and support to Operations staff in the implementation of, and adherence to, processes and workflows, controlled documents, tools, and templates to enhance the quality of deliverables
• He/She will facilitate SOP administrative functions and training for the Office of Clinical Research (OCR)
• He/She will identify process improvement opportunities, author and provide instruction on new processes for implementation
• Support process re-engineering, contribute to the development of training materials while serving as a subject matter expert
• Will participate in the creation of a quality and education program through which investigators and research staff involved in the conduct of clinical research, therapeutic and non-therapeutic protocols, will be educated and trained on current industry standards

Preferred

• Research Certification (e. g. CCRC, CHRC or CCRP) preferred
• Strong preference for a candidate with an Oncology background
• Industry, monitoring or QA experience preferred
• Research Certification CCRC
• Research Certification CHRC
• Research Certification
• Research Certification CCRP
• Oncology Background
• Industry Experience
• Monitoring Experience
• Quality Assurance Experience

Benefits

• Career growth and development opportunities, with clear pathways and ongoing support
• Comprehensive health and wellness resources that go beyond traditional benefits
• A wellness program that can help employees eliminate their medical plan deductible, reducing out-of-pocket healthcare costs
• Tuition reimbursement to support continued learning and advancement

Company

• Not-for-profit healthcare system with hospitals and outpatient care
• Coral Gables, Florida, US
• http://careers.baptisthealth.net/
• Founded in 1990
• 10001+ employees

Qualifications

• Bachelor of Science required
• A minimum of four years experience in clinical research and/or research
• Strong working knowledge of CFR 21, GCP and ICH Guidelines
• Research Certification (e. g. CCRC, CHRC or CCRP) preferred
• Strong preference for a candidate with an Oncology background
• Industry, monitoring or QA experience preferred

Required skills

• Clinical Research, Quality Assurance, Clinical Research Certification CCRC, Clinical Research Certification CHRC, Clinical Research Certification, Clinical Research Certification CCRP, CFR 21, Clinical Practice (GCP), ICH Guidelines, Oncology Research

Preferred skills

• Research Certification (e. g. CCRC, CHRC or CCRP) preferred, Industry, monitoring or QA experience preferred

Experience

• 4+ years