Compliance Specialist

Duties and Responsibilities

The Compliance Specialist will coordinate research compliance activities at the University's lakeside campuses to ensure regulatory compliance in human subjects research and animal research. This is accomplished by supporting the IRB and researchers engaged in human subject research. Compliance with the regulations requires administrative support of the chairperson of the Institutional Review Board for the Protection of Human Subjects (IRB). Secondary responsibilities include assisting the Associate Director of Research Compliance.

• Develops and implements appropriate procedures for the submission, review and approval, and amendment of research projects conducted by faculty, students, and staff; this includes ensuring that the University community is aware of such procedures and is informed in writing of all actions taken with respect to their individual protocols.
• Ensures that the IRB is appropriately constituted and that committee members are equipped with the appropriate knowledge to effectively assert their charge.
• Oversees the compilation and distribution of materials for Board meetings and attends the meetings to ensure that all actions are appropriately documented.
• Assists with the implementation of training programs to ensure that researchers are educated about their ethical and legal obligations and updates them of new requirements.
• Serves as a liaison between the Board and the University community to answer questions and provide assistance in any way possible.
• Creates and updates all on-line materials related to the support of human subjects research related compliance activities, e.g. applications, forms, policy manuals.
• Keeps abreast of all new regulatory requirements and drafts new policies whenever necessary.
• Compiles government reports as required by each regulatory agency/department or internal reports as requested by the Associate Director of Research Compliance.
• Promotes the facilitation of research at the University.

Minimum Education and/or Work Experience

Bachelor's degree required, Master's preferred, in ethics, the natural or social/behavioral sciences or related discipline. 2-5 years of experience in compliance management involving one or more of the following areas: human subjects' protection, lab animal care, biosafety, laboratory safety. Past experience in an organization that has achieved AAHRPP or AAALAC accreditation would be ideal.

Qualifications

• Language Ability: Candidates must have excellent writing skills in order to generate comprehensive reports, forms, correspondence, and procedure manuals. Oral communication skills in group settings are especially important given the significant amount of committee interaction that the position requires.
• Reasoning Ability: Strong analytical skills are essential for identifying ethical issues and interpreting regulatory documents; must be able to apply such skills to formulate procedures which are consistent with ethical guidelines and federal, state, and local laws. Some degree of ingenuity is needed for developing policies/procedures where only limited standardization exists.
• Past experience in an organization that has achieved AAHRPP accreditation would be ideal.
• Certification from the Council for Certification of IRB Professionals (CIP) would be ideal.

Computer Skills

Candidates must have experience with advanced MS Word processing, MS Excel or Spreadsheets, MS Access and MS PowerPoint; must be an adept user of Internet, e-mail and other office automation systems.

Diversity and Inclusion Statement

Diversity, Equity, and Inclusion: As one of the nation's largest Jesuit, Catholic universities, Loyola University Chicago fosters a transformative cultural experience that honors diversity, equity, and inclusion. We are committed to not only recruiting, but also retaining a diverse, mission driven workforce and enabling a culture of inclusiveness in an environment that values service excellence, stewardship, personal well-being, and professional development for all of our employees. Loyola University Chicago supports its staff and faculty with a wide array of affordable, comprehensive and competitive benefits centered on health and wellness, financial security, equity, and work-life balance. We actively seek those who wish to join our faculty, staff, and students in a community of diverse opinions, perspectives, and backgrounds supporting our Jesuit mission and striving toward the same goal of being persons for and with others.