Compliance Analyst, IRB

Title: Compliance Analyst, IRB

Department Org: Office of Research Compliance - 107990

Employee Classification: U1 - Unclassified PSA FT

Bargaining Unit: Professional Staff Association

Primary Location: MC AC

Shift:  1

Start Time:  8:30am   End Time:  5:00pm

Posted Salary: Salary will be based on education and experience

Job Description:

The IRB Compliance Analyst serves as a lead 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 complex 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 subject’s 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, development of departmental processes and forms, conflict of interest disclosures and the agreements/contracts related to federal, and industry sponsored human subject research studies.
The individual may participate in interviews, training, and evaluation 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.

Minimum Qualifications:

Bachelor’s degree in biomedical sciences.
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Minimum of three (3) years professional level experience (experience in the field that allowed overseeing, managing, and/or the ability to use independent judgement and discretion) 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.
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The individual must have a current knowledge, understanding, and experience with 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).
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Must possess high-level organization skills, the ability to handle of multiple assignments and perform against deadlines with frequent interruptions and competing priorities.
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Demonstrated ability to work both independently and in a team-oriented environment.
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Demonstrated experience and precision in data gathering, compilation information, and preparation of reports.
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Experience in handling confidential information and materials including industry and sponsored research contracts.
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Must be willing to pursue additional education and attend regulatory conferences.
and be able to obtain C.I.P. certification through the Public Responsibility in Medicine & Research (PRIM&R) organization within one year.
Communication and other skills:
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Skill in organizing resources and establishing priorities. Must be highly motivated, a self-starter, and very detail oriented.
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Must be able to maintain effective working relationships with personnel and professional staff.
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Must be diplomatic and resourceful, highly organized with knowledge and skills of priority-setting strategies.
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Demonstrated excellent verbal, written, and culturally appropriate communication skills (including technical writing)
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Ability to analyze and solve problems and to make evaluative judgments: Critical thinking.
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Knowledge of current and emerging issues and trends in human research protections and compliance
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Skill in examining and re-engineering operations and procedures, formulating policy, and developing and implementing new strategies and procedures.
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Demonstrated computer literacy including proficiency in e-mail, electronic calendars, Internet, databases, and other office system software. Knowledge of information systems and related

Preferred Qualifications:

Masters or J.D. degree
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Five (5) 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.

Conditions of Employment:

To promote the highest levels of health and well-being, the University of Toledo campuses are tobacco-free. 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. 

Equal Employment Opportunity Statement:

The University of Toledo is an equal opportunity employer. The University of Toledo does not discriminate in employment, educational programs, or activities on the basis of race, color, religion, sex, age, ancestry, national origin, sexual orientation, gender identity and expression, military or veteran status, disability, familial status, or political affiliation. 

The University is dedicated to attracting and retaining the best and brightest talent and fostering a culture of respect.

The University of Toledo provides reasonable accommodation to individuals with disabilities. If you require accommodation to complete this application, or for testing or interviewing, please contact HR Compliance at hrcompliance@utoledo.edu or 419-530-4747 between the hours of 8:30 a.m. and 5 p.m. or apply online for an accommodation request. 

Computer access is available at most public libraries and at the Office of Human Resources located in the Center for Administrative Support on the UToledo Main Campus.