Associate Compliance Analyst, IRB

The University of Toledo; Ottawa Hills (OH); Presencial; USD 40 000 - 49 000; Tempo integral

Resumo da oferta

The University of Toledo seeks an Associate Compliance Analyst, IRB to support leadership in ensuring compliance with federal, state, and institutional rules governing human subjects research.

The role focuses on protocol pre-review, analysis, and disposition of pre-review materials, including applications and informed consents, with responsibility for educating investigators and IRB members on regulatory expectations. Independent judgment and confidentiality are essential.

Qualificações

• Bachelor's degree required; two to three years of professional or research experience in human subjects research and regulatory compliance.
• Knowledge of DHHS/OHRP, FDA, HIPAA regulations, informed consent processes, and regulatory guidance and standards.
• High-level organization skills with ability to manage multiple tasks to meet deadlines.
• Ability to work independently and in a team-oriented environment.
• Experience handling confidential information and research contracts.
• Willingness to pursue further education and aim for CIP certification within three years.

Responsabilidades

• Perform protocol pre-review and analysis for human subject research oversight.
• Review and disposition materials related to pre-reviews, including applications and informed consent documents.
• Provide guidance on regulatory obligations and ethical conduct of human subjects research to investigators and IRB members.
• Educate staff and IRB members on regulatory requirements and ongoing compliance.
• Exercise independent discretion while contributing as a team member and safeguard confidential information.
• Support other areas of research compliance as needed and assist in training staff.

Conhecimentos

Regulatory compliance

Human subjects research

Data gathering & reporting

Confidential information handling

Teamwork

Organization skills

CIP certification pursuit

Formação académica

Bachelor's Degree

Master's or J.D. degree

Descrição da oferta de emprego

Title: Associate 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

Posted Salary: Minimum $ 44,985.20

Job Description

The Associate Compliance Analyst serves as a part of the leadershipteam in ensuring compliance with institutional, departmental,federal, and state regulations for the University’s oversight ofhuman subject research activities.

The position will be responsible for protocol pre-review andanalysis, and the review and disposition of materials related tothe pre-reviews. This includes but is not limited to applications,informed consents for research, data collection tools, OHRP and FDAregulations and research related agreements, proposals and awards.The individual will provide direction and guidance concerning therequirements and obligations for the ethical and compliant conductof human subjects research.

The position will require the individual to provide initial andongoing educational and regulatory guidance and direction toinvestigators, research office staff, students, and InstitutionalReview Board (IRB) members.

The individual filling this position will be required to exerciseindependent discretion and decision-making skills, yet alsofunction as a departmental team member. Responsibilities include,but are not limited to, the appropriate handling of confidentialand proprietary information, conflict of interest disclosures andthe agreements/contracts related to federal and industry sponsoredhuman subject research studies.

The individual may participate in interviews and training ofresearch office staff. The individual will also provide backupsupport to management and provide directives to staff asappropriate. The individual will provide support as needed in otherareas of research compliance such as responsible conduct ofresearch and biosafety.

Minimum Qualifications

• Bachelor’s Degree.
• Two to three years professional level or research experience inhuman subject research, research processes, and regulatorycompliance including but not limited to, the application ofDHHS/OHRP, FDA and HIPAA regulations, informed consent process,knowledge of investigational drug and device regulations,interpretation and application of regulatory guidance andstandards, knowledge of record keeping requirements meetingfederal, state and local laws, the application of institutionalpolicy, and compliance auditing. One (1) year of educational degreeattainment above the minimum may be substituted for every one (1)year of experience.
• The individual must have a current knowledge and understanding ofthe federal regulations pertaining to human subjects research (i.e.DHHS regulations, 45 CFR 46, FDA regulations, 21 CFR 56, HIPAAPrivacy and Security Rules).
• Must possess high-level organization skills, the ability tohandle of multiple assignments and perform against deadlines withfrequent interruptions and competing priorities.
• Demonstrated ability to work both independently and in ateam-oriented environment.
• Demonstrated experience and precision in data gathering,compilation information, and preparation of reports.
• Experience in handling confidential information and materialsincluding industry and sponsored research contracts.
• Must be willing to pursue additional education, attend regulatoryconferences, and be able to attain C.I.P. certification through thePublic Responsibility in Medicine & Research (PRIM&R)organization within three years.

Preferred Qualifications

• Masters or J.D. degree
• 3 years demonstrated work experience in human research, researchprocesses, 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, theUniversity of Toledo campuses are tobacco-free. Pre-employmenthealth screening requirements for the University of Toledo HealthScience Campus Medical Center will include drug and other requiredhealth screenings for the position.

Equal Employment Opportunity Statement

The University of Toledo is an equal opportunity employer. TheUniversity 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 bestand brightest talent and fostering a culture of respect.

The University of Toledo provides reasonable accommodation toindividuals with disabilities. If you require accommodation tocomplete this application, or for testing or interviewing, pleasecontact HR Compliance at [e-mail] 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 theOffice of Human Resources located in the Center for AdministrativeSupport on the UToledo Main Campus.

Advertised: 05 Oct 2026 Eastern Daylight Time

Applications close: 18 Oct 2026 Eastern Daylight Time