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Research Compliance Coordinator

Employer
University of Denver
Location
Colorado, Denver, USA
Salary
Negotiable

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Administrative Jobs
Academic Affairs, Research Staff & Technicians, Institutional & Business Affairs, Assessment, Accreditation & Compliance
Employment Type
Full Time
Institution Type
Four-Year Institution
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Job Details

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 conducting substantive pre-review screening of research submissions and aiding in the operations of the Institutional Review Board (IRB). The Research Compliance (or IRB) Coordinator 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 protocol reviewer and will advise researchers about human subjects protection issues. The successful candidate will bring to DU a strong background or interest in human subjects research administration, including a broad knowledge of federal research compliance regulations. This ideal candidate will have outstanding interpersonal skills, a collaborative style, and experience with faculty, staff, and students in achieving their research goals.

Remote work options available.

Essential Functions

  • Conduct pre-review analysis of IRB submissions to ensure applications are adequately prepared and to identify any missing information that would preclude the ability to conduct an adequate review and follows up with investigators to obtain corrections or needed information. Advises the research community about human subjects protection issues and institutional policies.
  • Manage the IRB email account to ensure timely and professional correspondence with the research communitys requests for information from the IRB office.
  • 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.
  • Support the Human Participant Protections Program by maintaining current knowledge of federal and state regulations, written policies and procedures, and ORSP business practices. Applies this knowledge to submission screening, IRB review, and consultation.
  • 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.

    • Knowledge, Skills, and Abilities

  • 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.

    • Required Qualifications

  • Bachelors degree.
  • At least two (2) years of experience of direct IRB regulatory experience or relevant experience as research staff that involves preparing research submissions to the IRB and maintaining the IRB paperwork at the research site. Ideally, this experience would involve an extensive background in critical thinking and analytical review of highly complex information.
  • Ability to recognize, analyze, and resolve potential issues/problems.
  • Highly effective interpersonal skills to handle sensitive and confidential situations.
  • Exhibits diplomacy and exceptional customer service.
  • High level of proficiency with Microsoft Office Suite.

    • Preferred Qualifications

  • Advanced degree in scientific research discipline.
  • IRB Professional Certification, or the ability and desire to attain it within two years.
  • Experience working in a university research administration office.
  • Direct IRB regulatory experience involving the review of social, behavioral, and educational research.
  • 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.

    • Working Environment

  • Standard office environment.
  • Unexpected interruptions occur often, and stress level is moderate to high.
  • Noise level is quiet to moderate.

    • Physical Activities

    1. Ability to sit in front of a computer for an extended period of time.
    2. Occasionally required to move about the office/campus with the capability of transporting objects up to 20 lbs.

    Work Schedule

    Monday - Friday, 8:00 a.m. - 4:30 p.m. Remote work options available.

    Application Deadline

    For best consideration, please submit your application materials by 4:00 p.m. (MST) March 22, 2023.

    Special Instructions

    Candidates must apply online through jobs.du.edu to be considered. Only applications submitted online will be accepted.

    Salary Grade Number:

    The salary grade for the position is 9.

    Salary Range:

    The salary range for this position is $55,000-$62,000.

    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 candidates 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:

  • Resume
  • 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, age (40 years and over in the employment context), religion, disability, sexual orientation, gender identity, gender expression, genetic information, marital status, veterans 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; Title III of the Americans with Disabilities Act of 1990, as amended in 2008; 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; and any other federal, state, and local laws, regulations, or ordinances that prohibit discrimination, harassment, and/or retaliation. For the university's complete Non-Discrimination Statement, please see non‑discrimination‑statement.

    All offers of employment are contingent upon satisfactory completion of a criminal history background check.

    Organization

    Founded in 1864—just a few years after the city of Denver itself was founded—the University of Denver is one of the country's premier private universities.

    The University's 125-acre campus, a few miles south of downtown Denver, is home to more than 11,500 students hailing from all regions of the United States and 83 other countries.

    The University offers:

    Regardless of what they study, University of Denver students embark on a personal educational journey that helps them find and follow their individual purpose.

    Collaborative, Experiential Learning

    Our students work closely with faculty, peers and members of the community on projects, research and fieldwork. They cross disciplines to discover new perspectives and approaches to problem solving.

    In and out of the classroom, our students learn by doing, whether they're collecting data in the field or putting theory into practice in a clinical setting.

    The University of Denver Culture

    Across the University of Denver’s many divisions, departments, and offices, supervisors are searching for new employees who strive to excel and innovate, prize integrity, and who value the opportunity to engage with the community.  The University is always looking for creative problem solvers, critical thinkers, and lifelong learners who want to know more and do more.

    At the University of Denver, our culture is steeped in ethics and social responsibility. As a result, our faculty and students represent a wide array of perspectives and enjoy the healthy dialogue that grows out of diversity. University of Maryland, Baltimore

    For all their differences, the members of our community are united by a common purpose: They're determined to confront society's most pressing challenges—everything from world health and the global economy to access to education.

    Company info
    Website
    Telephone
    3038717770
    Location
    2199 S. University Blvd.
     Denver
    Colorado
    80210
    US
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