IRB Compliance Analyst Office of Research and Creative Scholarship

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The University of Montana invites applications for the position of

Institutional Review Board (IRB) Compliance Analyst

. The IRB Compliance Analyst, reporting to the IRB Manager, will assist in the administration and coordination of IRB policies, procedures and activities related to the protection of the safety, rights and welfare of human research subjects and for ensuring institutional compliance with governmental regulations related to human subjects research. Sound knowledge and experience with the IRB process, including the ethical implications of scientific investigation and a solid understanding of federal and state regulations pertaining to human research, is required. Responsibilities of the IRB Compliance Analyst include:

Assist with the daily operations of the university’s IRB program;

Perform data entry and file management for protocol intake and out-take;

Conduct pre-review and full-review of IRB submissions for completeness and adherence with IRB policy, institutional requirements, and state/federal regulations;

Correspond with applicants to address needed corrections;

Draft, edit and issue approval letters to principal investigators (PIs);

Track all IRB protocol activity for the Missoula campus, UM Western, Helena College, Montana Tech, and the UM College of Technology; produce detailed monthly and annual statistical reports;

Review and revise all stock letters to PIs (notifications and determinations) as needed;

Assist with revising and updating IRB forms and templates;

Oversee all IRB recordkeeping (protocols, minutes, training, and correspondence);

Regularly meet with faculty and students for protocol consultations and pre-reviews;

Work with the IRB Manager to maintain a positive campus-wide IRB reputation by providing high quality reviews, consistency in determinations, stream-lined processing time, and proactive campus communication;

Stay updated and communicate in-depth knowledge of federal regulations pertinent to the protection of human subjects in research; advise IRB Manager, IRB, and research community;

Assist with updating IRB standard operating procedures (SOP’s) and IRB policies, procedures, and forms as needed per federal regulations and institutional policy;

Coordinate and schedule all IRB meetings, take minutes, and follow up on communication and correspondence resulting from the convened meetings;

Serve as the IRB training administrator for CITI SBER, Biomedical, and IRB Member courses; assist faculty, staff, and students with using the programs;

Facilitate campus education and outreach with news memos and class presentations;

Serve on the IRB as an alternate voting member after one year of employment or as qualified;

Execute independent review and signing authority for minimal risk studies, as authorized by the IRB Chair per federal regulation 45 CFR 46.110(b), including expedited, exempt, not human subjects research, continuation reports, amendment requests, and closures; and

Document issues of non-compliance (serious, continuing, or administrative), adverse events, and unanticipated problems; escalate and engage officials as appropriate.

The University of Montana is an Affirmative Action/Equal Opportunity employer and has a strong institutional commitment to the principle of diversity in all areas. In that spirit, we are particularly interested in receiving applications from a broad spectrum of qualified people who would assist the University in demonstrating its essential values of innovation and creativity, impact, openness, and partnership.

Position Details

Position is full-time, 1.0 FTE, MUS Contract and includes a comprehensive and competitive benefits package

including Insurance package, mandatory retirement plan, partial tuition waiver, and wellness program.

Salary for this position is $45,000 - $55,000 per year commensurate with qualifications.

Required Skills

Demonstrated proficiency with spreadsheet, database, and word processing applications.

Excellent English grammar, writing, and typing skills.

Ability to work independently and as part of a team in a fast-paced environment, maintain confidentiality at all times, and remain calm and pleasant under pressure.

Ability to efficiently collect, record, maintain, catalog and share information.

Knowledge of quantitative and qualitative research methodologies and statistical methods used in social/behavioral or biomedical research.

Within one year of hire, complete multiple courses and training in IRB administration.

Required Experience

Bachelor’s degree in a social, behavioral, or biomedical science.

Preferred Qualifications

Master’s degree in a social, behavioral, or biomedical science.

One or more years of experience serving on an Institutional Review Board (IRB).

Two years of experience conducting research with human subjects or working in an IRB office.

Certified IRB Professional or ability to obtain CIP certification within one year of employment.

About

UM

and the

Office of Research and Creative Scholarship

The University of Montana is flagship, research institution with approximately 10,000 undergraduate and graduate students. It is located in Missoula, a culturally vibrant community of about 75,000, surrounded by mountains and three rivers converge. Abundant recreational opportunities in surrounding state and national forests and nearby Glacier National Park and Yellowstone National Park complement a thriving intellectual atmosphere. The University of Montana offers eligible employees a generous benefits package that positively separates UM from other local employers and offers many programs and policies to support work-life balance for its employees.

UM's Office of Research and Creative Scholarship supports the educational and research mission of the University through advocacy and advancement of basic and applied research, creative work, and academic scholarship, and fosters an environment where research, scholarly activities, entrepreneurship, and economic development thrive. UM is designated a R1 research university by the Carnegie Foundation, placing UM within the top tier of American doctoral research universities.

The mission of the UM Institutional Review Board (IRB) is to ensure the protection of human participants in research, maintain federal regulatory compliance, and facilitate research at the University of Montana.

In addition to the Missoula campus, the IRB Office provides oversight for research involving human participants for UM Western, Helena College, Montana Technological University, and Missoula College.

To learn more about the University of Montana, Missoula, and the State of Montana, please visit the links below.

University of Montana

University Highlights

City of Missoula

Destination Missoula

Video: There's This Place

Missoula Area Chamber of Commerce

State of Montana

Visit Montana

Criminal Background Investigation is required prior to Offer of Employment.

In accordance with University policy, finalists for this position will be subject to criminal background investigations.

ADA/EOE/AA/Veteran's Preference.

Reasonable accommodations are provided in the hiring process for persons with disabilities. For example, this material is available in alternative format upon request. As an Equal Opportunity/Affirmative Action employer, we encourage applications from minorities, veterans, and women. Qualified candidates may request veterans’ or disabilities preference in accordance with state law.

References

*References not listed on the application materials may be contacted; notice may be provided to the applicant.

Testing

Individual hiring departments at UM may elect to administer pre-employment tests, which are relevant to essential job functions.

E mployment Eligibility.

All New Employees must be eligible and show employment eligibility verification by the first date of employment at UM, as legally required (e.g., Form I-9).

Company info

The University of Montana
Website : https://www.umt.edu