Associate Compliance Analyst

The University of Toledo • Toledo, OH

2d • Onsite

About The Position

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. The position will be responsible for protocol pre-review and analysis, and the review and disposition of materials related to the pre-reviews. This includes but is not limited to applications, informed consents for research, data collection tools, OHRP and FDA regulations and research related agreements, proposals and awards. The individual will provide direction and guidance concerning the requirements and obligations for the ethical and compliant conduct of human subjects’ research. The position will require the individual to provide initial and ongoing educational and regulatory guidance and direction to investigators, research office staff, students, and Institutional Review Board (IRB) members.

The individual filling this position will be required to exercise independent discretion and decision-making skills, yet also function as a departmental team member. Responsibilities include, but are not limited to, the appropriate handling of confidential and proprietary information, conflict of interest disclosures and the agreements/contracts related to federal, and industry sponsored human subject research studies.

The individual may participate in interviews and training of research office staff. The individual will also provide backup support to management and provide directives to staff as appropriate. The individual will provide 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.
• 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
• Ability to handle 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

Nice To Haves

• Masters or J.D. degree
• Three (3) years demonstrated work experience in human research, research processes, and regulatory compliance including but not limited to, the application of DHHS/OHRP, FDA and HIPAA regulations
• Willingness to pursue additional education
• Willingness to attend regulatory conferences
• Ability to attain C.I.P. certification through the Public Responsibility in Medicine & Research (PRIM&R) organization within three years

Responsibilities

• Protocol pre-review and analysis
• Review and disposition of materials related to pre-reviews (applications, informed consents for research, data collection tools, OHRP and FDA regulations, research related agreements, proposals and awards)
• 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
• Function as a departmental team member
• Handle confidential and proprietary information
• Handle conflict of interest disclosures
• Handle 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
• Provide support as needed in other areas of research compliance such as responsible conduct of research and biosafety

Benefits

• Pre-employment health screening requirements for the University of Toledo Health Science Campus Medical Center will include drug and other required health screenings for the position.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level