RESEARCH REGULATORY QA COORDINATOR Job Job in Cleveland, Ohio US
RESEARCH REGULATORY QA COORDINATOR Job
RESEARCH REGULATORY QA COORDINATOR Reference Title HR Use Only: Research Regulatory QA Coordinator Hospital: Cleveland Clinic Main Campus Family Health Centers Facility: CLEVELAND CLINIC FOUNDATION (MAIN CAMPUS) Department: CANCER CENTER RESEARCH Job Code: T99663 Pay Grade: 13 Schedule: Full Time Shift: Days Hours: 8am - 5pm Job Details: Summary: Responsible for implementing and maintaining the Research Regulatory Quality Assurance (QA) Program for the Institute in collaboration with Institute and central research administration management. Serves as regulatory resource and is responsible for all Institute research QA activities, including the implementation of quality assurance standards, assessment of adherence to those standards and education with respect to application of those standards based on the regulations. Job Responsibilities: Coordinates the implementation and maintenance of the Research Regulatory Quality Assurance (QA) Program for the Institute in collaboration with Institute and central research administration management. Responsible for all Institute Q/A auditing, monitoring and training. Assists with the establishment of standard operating policies, procedures and guidelines for the conduct of research that are in alignment with those of the sponsoring organization, external regulatory agencies and central research administration offices. Serves as a regulatory liaison with local, state and federal external agencies, communicating directly with agency personnel as necessary. Coordinates the implementation and maintenance of the research education program, tracking participation and certification. Coordinates all regulatory and quality audits and inspections, identifying and resolving compliance issues and concerns, developing and implementing quality improvement plans and defining standard scope of audit to mitigate future risk and reporting on research compliance activities. May provide monitoring of research projects. Participates in the evaluation of research industry best practices for research compliance and quality assurance to develop metrics that drive improvement. Serves as research team liaison, providing communication and consultation services as needed. Maintains records, files and data for research regulatory and quality assurance efforts. Other duties as assigned. Education: Bachelor's Degree in healthcare, quality management or a related discipline. Experience: Minimum three years research experience with a focus on research quality assurance and compliance. Additional years of related experience may offset the degree requirements. Research experience coordinating regulated research projects preferred. Licensure/Certification/Registration: Within 90 days of hire, must successfully complete certification in Human Subject Research as required by the Responsible Conduct of Research Guidelines as adopted by Cleveland Clinic. Research certification from a recognized clinical research organization may be preferred. Physical Requirements: A high degree of dexterity to produce materials on a computer. Requires normal or corrected vision and hearing to normal range. Extensive sitting and frequent walking, occasional lifting or carrying of 5 to 15 pounds. May have some exposure to communicable diseases or body fluids. May require working irregular hours. Category: Research Additional Requirments / Information