Associate Compliance Analyst - 501089

About the role

The position serves as a part of the leadership team in ensuring compliance with institutional, departmental, federal, and state regulations for the University’s oversight of human subject research activities.

Responsibilities

• Protocol pre-review and analysis
• Review and disposition of materials related to the pre-reviews
• Provide direction and guidance concerning the requirements and obligations for the ethical and compliant conduct of human subjects’ research
• Provide initial and ongoing educational and regulatory guidance and direction to investigators, research office staff, students, and Institutional Review Board (IRB) members
• Exercise independent discretion and decision-making skills, yet also function as a departmental team member
• Handle confidential and proprietary information, conflict of interest disclosures, and agreements/contracts related to federal, and industry sponsored human subject research studies
• Participate in interviews and training of research office staff
• Provide backup support to management and provide directives to staff as appropriate
• Support as needed in other areas of research compliance such as responsible conduct of research and biosafety

Requirements

• Bachelor’s Degree
• Two to three (2-3) years professional level or research experience in human subject research, research processes, and regulatory compliance including but not limited to, the application of DHHS/OHRP, FDA and HIPAA regulations, informed consent process, knowledge of investigational drug and device regulations, interpretation and application of regulatory guidance and standards, knowledge of record keeping requirements meeting federal, state and local laws, the application of institutional policy, and compliance auditing
• One (1) year of educational degree attainment above the minimum may be substituted for every year of experience
• A current knowledge and understanding of the federal regulations pertaining to human subjects’ research (i.e., DHHS regulations, 45 CFR 46, FDA regulations, 21 CFR 56, HIPAA Privacy and Security Rules)
• High-level organization skills, the ability to handle of multiple assignments and perform against deadlines with frequent interruptions and competing priorities
• Demonstrated ability to work both independently and in a team-oriented environment
• Demonstrated experience and precision in data gathering, compilation information, and preparation of reports
• Experience in handling confidential information and materials including industry and sponsored research contracts
• Willingness to pursue additional education, attend regulatory conferences, and be able to attain C.I.P. certification through the Public Responsibility in Medicine & Research (PRIM&R) organization within three years

Qualifications

• Bachelor’s Degree
• Two to three (2-3) years professional level or research experience in human subject research, research processes, and regulatory compliance including but not limited to, the application of DHHS/OHRP, FDA and HIPAA regulations, informed consent process, knowledge of investigational drug and device regulations, interpretation and application of regulatory guidance and standards, knowledge of record keeping requirements meeting federal, state and local laws, the application of institutional policy, and compliance auditing
• One (1) year of educational degree attainment above the minimum may be substituted for every year of experience
• A current knowledge and understanding of the federal regulations pertaining to human subjects’ research (i.e., DHHS regulations, 45 CFR 46, FDA regulations, 21 CFR 56, HIPAA Privacy and Security Rules)
• High-level organization skills, the ability to handle of multiple assignments and perform against deadlines with frequent interruptions and competing priorities
• Demonstrated ability to work both independently and in a team-oriented environment
• Demonstrated experience and precision in data gathering, compilation information, and preparation of reports
• Experience in handling confidential information and materials including industry and sponsored research contracts
• Willingness to pursue additional education, attend regulatory conferences, and be able to attain C.I.P. certification through the Public Responsibility in Medicine & Research (PRIM&R) organization within three years