Akron Children's Hospital Careers
Regulatory Compliance Auditor
Shift Information: Day Job
Develops an annual audit plan with the Compliance & Privacy Officer and determines protocols to audit based on identified risk areas or operational requests. Conducts audits to assure compliance with study or sponsor SOPs, GCP, and expectations for data accuracy and completeness. Develops, executes and maintains audit schedules according to the needs of the project. Develops audit reports for review by the Compliance & Privacy Officer, Research Institute leadership and the IRB Chairperson. Plans and conducts audits independently. Drafts and finalizes audit reports. Works closely with Research Institute Leadership, Compliance & Privacy Officer, research staff, investigators and the Institutional Review Board. Uses in-depth understanding of appropriate GCP compliance and other applicable regulations and laws to provide guidance to regarding compliance issues. Ensures that the implemented research audit program is appropriate in scope, that identified issues are corrected and that investigators and staff are educated.
Baccalaureate degree required. Minimum of 5 years clinical experience with 2 years clinical research experience or 5 years IRB/Research Audit Experience required. Knowledge of applicable FDA and OHRP regulations, GCP compliance and other applicable regulations, laws and guidelines required. Must possess excellent project management and organizational ability. Demonstrates manage multiple tasks or projects and prioritize a workload, leadership and communication skills with interdisciplinary team, professional colleagues and staff. Must be detail oriented, proficient in word processing, spreadsheet and database use, and other computer software programs for data analysis, and presentations. Ability to work professionally with highly confidential information diplomatically.
Akron Children's Hospital is an Equal Opportunity Employer of Minorities, Females, Protected Veterans, and Individual with Disabilities.
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