- Performs regulatory review and analysis of research applications submitted to the DU IRB for consistency, completeness, and compliance with federal and state regulations and DU IRB policies and procedures.
- Solves routine issues within the framework of federal regulations, laws and guidance to human subjects protection and DU IRB policies and procedures.
- Provides guidance and consultation to investigators regarding the interpretation of the Code of Federal Regulations (CFRs), HIPAA and FERPA laws, and NIH and NSF policies, pertaining to human subjects research.
- Determines the appropriate level of review for IRB research submissions and will be designated to conduct exempt and expedited reviews.
- Advises the research community about human subjects protection issues and institutional policies.
- Develops and presents educational programs for IRB members, DU research courses, and other speaking engagements on research as requested by the DU community.
- Assists in the management of the electronic management system; maintaining the database to track and process all active, pending, and terminated protocols/proposals.
- Attends IRB full committee meetings, contributes to the development of meeting agendas, minutes and stipulations letters.
- Must have the ability to work as a team member, be very detail-oriented, and have the personality that can adapt to a stressful work environment.
- Excellent interpersonal, oral, and written communication skills to work effectively with affiliated and unaffiliated researchers, IRB members, and other DU department and college personnel.
- Ability to professionally communicate complex information to a wide variety of audiences, both written and orally.
- Knowledge and practical application for assessing and categorizing human subjects research proposals per OHRP and FDA regulations. Demonstrates knowledge-based understanding of the IRB review process.
- Ability to independently manage several projects at once, and ability to work under pressure to meet time-sensitive deadlines.
- Strong customer service skills and well-developed communication skill level. Demonstrated ability to interact effectively with a diverse population.
- Demonstrated organizational skills and attention to detail.
- Ability to uphold ethical practices amid complicated and confidential situations.
- Experience using Microsoft Professional Suite software, Zoom, and Microsoft Teams.
- Demonstrated ability to utilize skills in problem solving and ability to consider multiple alternatives. Must be able to make appropriate decisions independently and seek assistance as appropriate.
- Evidence of self-motivation and ability to work independently, and within a team, building professional work relationships with coworkers, faculty, staff, and administrators.
- Demonstrated ability to multi-task effectively and to take initiative to identify, prioritize, and plan tasks and projects necessary to meet individual and department goals.
- Bachelors degree.
- At least three (3) years of experience of direct IRB regulatory experience reviewing and processing human subjects research applications.
- Experience working with electronic submission systems; ability to learn and master proprietary software, IRBNet, as this program is critical to day-to-day operations.
- Knowledge and practical application of research ethical principles and federal regulatory requirements.
- Advanced degree in scientific research discipline.
- IRB Professional Certification.
- Experience working in a university research administration office.
- Direct IRB regulatory experience involving the review of social, behavioral and educational research.
- Experience using the electronic submission system IRBNet.
- Standard office environment.
- Unexpected interruptions occur often, and stress level is moderate to high.
- Noise level is quiet to moderate.
- Ability to sit in front of a computer for an extended period of time.
- Occasionally required to move about the office/campus with the capability of transporting objects up to 20 lbs.
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Research Compliance Analyst - Denver, United States - University of Denver
Description
Research Compliance AnalystJob no: 497243
Work type: Staff Full-Time
Location: Denver, CO
Categories: Business Operations / Services, Admin / Executive / Office Support, Research
Division: Office of Resrch & Sponsored Progs
The Office of Research Integrity & Education (ORIE) ensures active adherence to the ethical principles and professional standards essential for conducting research. ORIE is the key point of contact for providing regulatory guidance and processing research proposal approvals to faculty, staff and student investigators.
Position Summary
This position has the primary responsibility for providing subject matter expertise in the review of human subject research protocols. The Research Compliance Analyst will be part of a team working to create a culture of compliance at the University of Denver (DU) through ensuring compliance with all federal, state and local regulations, policies and guidelines to create a successful human subjects protection program. This position will serve as a designated reviewer, advise researchers about human subjects protection issues, and conduct training programs for staff, researchers, administrators and students.
The successful candidate will bring to DU a strong background in human subjects research administration, including a broad knowledge of federal research compliance regulations. This position will have outstanding interpersonal and management skills, a collaborative style, and experience with faculty, staff, and students in achieving their research goals.
Remote work options available.
Essential Functions
The University's administrative offices are open Monday - Friday, 8:00 a.m. - 4:30 p.m. Work schedule may vary.
Remote work options available.
Application Deadline
For consideration, please submit your application materials by 4:00 p.m. (MST) May 14, 2024.
Special Instructions
Candidates must apply online through to be considered. Only applications submitted online will be accepted.
Salary Grade Number:
The salary grade for the position is 11.
Salary Range:
The salary range for this position is $72,000 - $81,000.
The University of Denver has provided a compensation range that represents its good faith estimate of what the University may pay for the position at the time of posting. The University may ultimately pay more or less than the posted compensation range. The salary offered to the selected candidate will be determined based on factors such as the qualifications of the selected candidate, departmental budget availability, internal salary equity considerations, and available market information, but not based on a candidate's sex or any other protected status.
Benefits:
The University of Denver offers excellent benefits, including medical, dental, retirement, paid time off, tuition benefit and ECO pass. The University of Denver is a private institution that empowers students who want to make a difference. Learn more about the University of Denver.
Please include the following documents with your application:
1. Resume
2. Cover Letter
The University of Denver is an equal opportunity employer. The University of Denver prohibits discrimination on the basis of race, color, national origin, ancestry, age, religion, creed, disability, sex, sexual orientation, gender identity, gender expression, marital status, pregnancy, genetic information, military enlistment, or veteran status, and any other class of individuals protected from discrimination under federal, state, or local law, regulation, or ordinance in any of the University's educational programs and activities, and in the employment (including application for employment) and admissions (including application for admission) context, as required by Title IX of the Education Amendments of 1972; the Americans with Disabilities Act; Section 504 of the Rehabilitation Act of 1973; Title VI and VII of the Civil Rights Act of 1964; the Age Discrimination Act of 1975; the Age Discrimination in Employment Act of 1967; Equal Pay Act; Colorado Equal Pay for Equal Work Act; the Colorado Protecting Opportunities and Workers' Rights ("POWR") Act; and any other federal, state, and local laws, regulations, or ordinances that prohibit discrimination, harassment, and/or retaliation. For more information, please see the University of Denver's ">Non-Discrimination-Statement.
All offers of employment are contingent upon satisfactory completion of a criminal history background check.
Advertised: April 16, 2024
Applications close: May 14, 2024
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