Senior Research Compliance Analyst

• Senior Research Compliance Analyst (Research Compliance Analyst 3) under the direction of the Senior Director, Research Compliance, within the College of Medicine's (COM) Office of Research;
• supports, promotes, and ensures legally compliant and ethical research practices; collaborates with researchers to ensure compliance with federal, state, and local laws and regulations, best practice, guidance, quality standards, as well as University policy;
• informs and assists faculty, staff, and student researchers in navigating regulatory processes and requirements; provides advice and counsel to ensure compliance with approved protocols;
• reviews complex research submissions; prepares research teams for regulatory audits; collects and analyzes data to support the research compliance program;
• evaluates impact of regulatory requirements for continuous quality improvement; develops and oversees research compliance resources;
• participates in the creation and delivery of educational training programs, tools and materials; serves as a unit resource for development of research compliance products and communications;
• completes work primarily through individual efforts or by participation on functional or project teams; receives general guidance;
• work is reviewed for purpose of meeting objectives; may coordinate, influence, or review the work of others; may be the primary owner / authority on a given program or process;
• maintains extensive knowledge of human subjects research (HSR) and Institutional Review Board (IRB) functions; plans and leads audits;
• provides guidance and implements corrective action plans; identifies training and educational needs; may perform compliance inquiries and other research compliance investigations;
• continually monitors federal regulations and processes to identify and interpret new and updated requirements; may provide regulatory updates to investigators, research staff, and university partners on regulations;
• may develop and provide required regulatory reports and associated documentation; engages in regular monitoring of compliance files;
• receives and safeguards information on sensitive, confidential and privileged matters; works to build consensus and organizational collaboration;
• effectively conveys complex information to mitigate noncompliance and achieve buy-in; assists in the development of support auditors;
• takes a lead role in the refinement and development of auditing instruments and compliance tools; assists in onboarding and training new staff;
• serves as a resource for less experienced colleagues; works to build consensus and organizational collaboration; possesses strong team orientation, ability to multi-task and meet deadlines;

demonstrates professionalism, courtesy and integrity; performs other duties as assigned to support COM Office of Research Compliance (COMOR-C) activities.

Minimum Education Required

Bachelor's Degree in a biological, health science, legal, or related discipline, required. Advanced degree in relevant field may be desirable.

Required Qualifications

Bachelors Degree in a biological, health science, legal or related discipline required considerable experience in an auditing and compliance capacity in an industry, government, healthcare, or academic research setting that provides knowledge of fundamental theories, principles, and concepts.

• Ability to apply specialized expertise to achieve results; ability to emphasize in-depth knowledge, project management, and influencing skills at a more seasoned level;
• ability to cultivate relationships to produce optimal results; ability to apply industry knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform tasks and projects;
• ability to work on complex projects of large scope; ability to refer to precedents and defined parameters; extensive knowledge of research regulations, best practice, guidance, quality standards, and compliance required ;
• experience in protocol, assessment and with regulatory documents required; experience and knowledge of human subject research required;

experience and knowledge of animal research desired; and federal or industry sponsor processes and requirements preferred.

Professional research certification (e.g., CCRP, CRA, CHRC, CIP, CPIA) desired; completion or renewal of relevant Collaborative Institutional Training Initiative (CITI) courses (e.

g., Human Subjects Protection Biomedical, Revised Common Rule) online courses within first 90 days of hire. 4 years of relevant experience required.

4-8 years of relevant experience preferred.

Requires successful completion of a background check; qualified candidates may be asked to complete a pre-employment physical including a drug screen.

Function : Research Administration

Sub-Function : Research Compliance