Research Compliance Analyst, under the direction of the Senior Director, Research Compliance and Operations, assists with the oversight and monitoring of regulatory research compliance within the College of Medicine's Office of Research (COMOR); collaborates with researchers to ensure compliance with federal, state, and local laws and regulations, best practice, guidance, quality standards, College and University policy; participates in monitoring the compliance 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 University partners; serves as a unit resource and provides guidance and 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; assists in onboarding and training new staff; plans and performs audits, working closely with management on escalated issues; participates in writing regulatory reports and in developing associated documentation including corrective action plans for audited or investigated researchers; manages various programs or processes as assigned by management.

Minimum Education Required

Bachelor's degree, or equivalent combination of education and experience.

Minimum Required Qualifications

Minimum 2 years experience in a research, compliance, and/or auditing, in an
industry, government, 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 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 a hybrid position that will require an onsite presence according to business needs.

Desired Qualifications
Experience in evaluating research studies (e.g., informed consent forms) and knowledge of regulatory documents; experience with and knowledge of human and animal research compliance, Institutional Animal Care and Use Committee, Office of Laboratory Animal Welfare, American Association for Laboratory Animal Science processes; Utilizes industry knowledge to influence others directly or indirectly, while building consensus and organizational collaboration; experience with and knowledge of federal or industry sponsor processes and requirements; professional research certification (e.g., CCRP, CRA, CHRC, CIP,
CPIA). Collaborative Institutional Training Initiative (CITI) (e.g., Human Subjects Protection Biomedical, Revised Common Rule) online courses or completion within first 90 days of hire.

Function: Research Administration

Sub-Function: Research Compliance

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