IRB Manager Office of Research and Creative Scholarship

Profile

Application instructions are located at the bottom of the page. Please apply directly through **MEMBERS ONLY**SIGN UP NOW***.'s career portal UM Jobs at ****. Do not apply through Indeed.com or use easy apply through Indeed.com
**MEMBERS ONLY**SIGN UP NOW***. invites applications for the position of
Institutional Review Board (IRB) Manager
. Reporting to the Associate Vice President for Research Compliance, the Institutional Review Board (IRB) Manager plays a critical role in ensuring compliance with federal regulations and university policies related to research involving human subjects. Research investigator violations in non-exempt human subjects research can trigger a for-cause audit by any federal funding agency, which can have a steep price for the university. Among possible federal enforcement actions, an agency can issue warning letters — and publicize them — or disqualify researchers from further research activities. The funding agency may also withhold research money from an individual or the entire institution.
The IRB Manager is responsible for oversight, 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. Expert knowledge and experience with the IRB process, including the ethical implications of scientific investigation and an intimate understanding of federal and state regulations pertaining to human research, is required. The IRB Manager must successfully manage professional and collegial relationships with the university faculty, staff, and students as well as with federal agency officials. Specific responsibilities include the following:
Oversee the daily operations and management of the university’s IRB program.
Execute independent review and signing authority for all 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.
Handle and document issues of non-compliance (serious, continuing, or administrative), adverse events, and unanticipated problems; escalate and engage officials as appropriate.
Regularly meet with faculty, staff, and students for protocol consultations and preliminary reviews.
Work with the Chair and Associate Vice President to maintain a positive campus-wide IRB reputation by providing high quality reviews, consistency in determinations, stream-lined processing time, and proactive campus communication.
Serve as the Protocol Registration System (PRS) Administrator for ClinicalTrials.gov for the university.
Supervise and train an administrative associate on data entry and file management for protocol intake and out-take.
Stay updated and communicate in-depth knowledge of federal regulations pertinent to the protection of human subjects in research; advise Chair, IRB, and research community.
Track all IRB protocol activity for the Missoula campus, UM Western, Helena College, Montana Tech, and Missoula College; produce detailed monthly and annual statistical reports.
The IRB Manager is an ex-officio alternate member of the IRB.
Review and revise all stock letters to Pls (notifications and determinations) as needed.
Revise and regularly update all IRB forms and templates.
Oversee all IRB recordkeeping (protocols, minutes, training, and correspondence.
Review and propose revisions to IRB policies and procedures, as needed, to comply with evolving federal regulations and institutional policy.
Update, maintain, and create all IRB standard operating procedures (SOP’s).
Coordinate and schedule all IRB meetings, write agendas, prepare and distribute review materials, take minutes, and follow up on communication and correspondence resulting from the convened meetings.
Keep the Federal Wide Assurance and IRB registration up-to-date and approved.
Serve as the IRB training administrator for CITI IRB coursework; assist faculty, staff, and students with using the programs as well as the NIH and UM courses.
Facilitate campus outreach with news memos, departmental and class presentations, webinars, and open house events; maintain and regularly update the IRB website content.
Administer the IRB’s electronic application and file submission portal and database.
**MEMBERS ONLY**SIGN UP NOW***. 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, (select one) 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 $55,000 - $70,000 per year commensurate with qualifications.
Required Skills
Demonstrated independent thinking and problem-solving abilities
Demonstrated professionalism, customer service skills, and the ability to coordinate multiple activities simultaneously
Ability to interact with institutional colleagues with the utmost professionalism and confidentiality in both verbal and written communications
Demonstrated proficiency with spreadsheet, database, and word processing applications
Demonstrated written and oral communications
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
Possess exemplary organizational and interpersonal skills
Effectively collect, record, maintain, catalog and share information
Understand federal regulatory agency policy and oversight concerning the use of human subjects in research
Required Experience
Master’s degree or higher in a scientific, health, business, or public administration field that requires scholarly research.
Along with relevant experience, a master’s degree is typically the minimally accepted level to serve on an Institutional Review Board in an academic setting.
The knowledge of quantitative and qualitative research methods that is achieved at this level is critical to understanding and competently reviewing complex research protocols.
Preferred Qualifications
Two (2) years prior experience serving as an IRB member and/or working in the area of research administration.
Prior experience working with tribal IRBs, administrators, or research programs.
In-depth knowledge of the Belmont Report, 45 CFR 46, 21 CFR 50 & 56, HIPAA, and FERPA regulations is preferred.
Mastery of bundled software, including MS Word, Excel, PowerPoint, Outlook, internet browsers, along with desktop publishing and website editing skills.
Prior working experience with human subjects research administration software or SaaS modules (e.g., Cayuse Human Subjects Research module).
Proven to be a mature professional exemplifying the work ethic, leadership qualities, and overall level of performance required.
Provides leadership and direction, applying strategic thinking and results orientation to ensure the IRB mission is achieved.
Demonstrates advanced diplomacy and an understanding of the importance of relationships when working with diverse internal and external customers.
Uses strong written, verbal, and interpersonal skills, along with negotiating and consensus building, to communicate effectively.
Understands policy development and compliance issues within a higher education research administration setting.
Applies solid analytical and problem-solving experience along with skills to recognize and resolve difficult and complex situations.
About
UM
and the Office of Research and Creative Scholarship
**MEMBERS ONLY**SIGN UP NOW***. is a unit of the Montana University System with more than 11,000 undergraduate and graduate students and 500 full-time faculty members. It is located in Missoula, a culturally vibrant community of about 70,000, surrounded by mountain grandeur which was recently ranked in the “ top 20 best college towns with a population of less than 250,000
” by the American Institute for Economic Research and ranked 9
th
in Outside Magazine’s “ The 16 Greatest Places to Live in America
” in 2014. Many national publications recognize Missoula for its high quality of life
. Abundant recreational opportunities in surrounding state and national forests and nearby Glacier National Park and Yellowstone National Park complement a thriving intellectual atmosphere.
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 **MEMBERS ONLY**SIGN UP NOW***..
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 **MEMBERS ONLY**SIGN UP NOW***., 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

Sign Up Now - EducationCrossing.com