Research Compliance Analyst under the direction of the Deputy Director, SOAR assists with the oversight and monitoring of regulatory research compliance within the Department of Psychiatry and Behavioral Health. This position collaborates with researchers to ensure compliance with federal state and local laws and regulations; provides best practice guidance; implements and monitors quality standards; participates in monitoring the SOAR mailbox and phone and responding to research compliance inquiries, escalating to leadership as necessary. Provides guidance to researchers in navigating regulatory processes and requirements to ensure compliance with approved protocols reviews and analyzes complex research submissions (e.g. Quality Pre-Review) seeking guidance from management, as needed. Assists in preparing research teams for regulatory audits, assists in providing regulatory updates to investigators research staff and SOAR and Department partners, serves as a resource and provides guidance, responds to inquiries related to programs and projects, continually monitors federal regulations and processes to identify and interpret new and updated requirements, assists in identifying training and educational needs for stakeholders, works closely with team and leadership in the development and delivery of educational training programs tools and materials, participates in the evaluation of the impact of regulatory requirements for continuous quality improvement, works closely with management to develop and oversee research compliance resources related to specific programs and projects assigned by management, engages in regular monitoring of compliance files, participates in study team offboarding process, assists in onboarding and training new staff, plans and performs routine audits working closely with management on escalated issues, participates in writing regulatory reports and in developing associated documentation including corrective action plans for audited studies, manages various programs or processes as assigned by management.
Bachelor's degree or equivalent combination of education and research experience. Minimum 2 years experience in a research compliance and/or auditing in a healthcare and/or academic research setting. Excellent computer skills including experience with MS Office, Teams and Zoom. Ability to multi-task, meet deadlines, apply critical thinking and has excellent attention to detail. Requires successful completion of a background check. Selected candidate may be asked to complete a pre-employment physical including a drug screen. This is primarily an on-site position to meet business needs.
Experience in evaluating research studies (e.g. protocols, informed consent forms) and knowledge of regulatory documents; experience with and knowledge of human research compliance regulations, Institutional Review Board (IRB) and Good Laboratory processes; Utilizes knowledge to influence others directly or indirectly while building consensus and organizational collaboration; experience with and knowledge of federal or industry sponsor processes. Collaborative Institutional Training Initiative (CITI) (e.g. Human Subjects Protection, Social and Behavioral Practices) online courses or completion within first 90 days of hire
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