The Office of Research Integrity and Education (ORIE) is part of the Office of Research and Sponsored Programs (ORSP) that supports the University of Denver community in their pursuit of research. ORIE is the key point of contact for faculty, staff and student investigators for guidance on research conduct and compliance.
The Research Compliance Monitor has the responsibility to identify areas of research noncompliance, or potential noncompliance, and to advise and consult with researchers, department and college administrators, the research compliance committee members and staff to correct problems to ensure that research involving human subjects, animals and biological materials are of high quality and meets University and Regulatory Agency standards. The work is based on established University of Denver (DU) research policies established through the Institutional Review Board, Institutional Animal Care and Use Committee and Institutional Biosafety Committee and University policies. The Monitor will carry out independent audits of research studies, investigators, operations or departments for research compliance. This compliance position will review research study information and overview research processes to gain an appreciation of the overall quality and compliance for a given study, principal investigator or department. The monitor compiles and analyzes data, prepares and delivers a report, and makes recommendations. This position will be part of a team working to create a culture of compliance at DU ensuring compliance with all federal, state and local regulations, policies and guidelines to create a successful research compliance program. The successful candidate will bring to DU a background in research administration, including broad knowledge of compliance regulations. S/he will have outstanding interpersonal and management skills, a collaborative style, and experience working with university administrators, faculty, staff, and students.
The goal of the following activities is to ensure that all operational priorities are aligned with the DUs research mission.
Ensures that the research operations meet legal and regulatory requirements and are in compliance with complex federal, state, and local regulations regarding the activities of human subject’s research, animal welfare and biosafety.
Assists the Research Integrity Director in the development and maintenance of compliance programs, including, but not limited to educational materials, associated forms and policies and internal procedures.
Monitors changes in laws, regulations and technology and advises management how that may affect operations.
Conducts and reports the regulatory review of initial and continuing research protocol submissions to ensure federal regulatory compliance.
Reviews research projects throughout the campus and evaluates whether appropriate regulatory reviews were conducted.
Substantively interprets federal and state regulations when conducting an analysis of the research project.
Including determining regulatory risks whether, internal or external to the Institution. Facilitates compliance audits.
Communicates with investigators, compliance committees and appropriate parties, in written reports and correspondence the specific issues regarding non-compliance.
Schedule, conduct, and provide timely reports of noncompliance investigations of Principal Investigators, audits and assessments of internal systems/process audits to assure compliance with SOPs and applicable regulations and guidelines.
Routine and administrative directed site visits of domestic investigators approved by the DU IRB, IACUC, or IBC, as requested.
Provides regulatory, ethical, and method advice to individual faculty and staff for research proposals.
Recommends improvements for enhancing communication between the compliance committees, university departments and colleges, researchers and staff based upon compliance audits and feedback.
Contributes to the development of quality assurance initiatives, as well as other special projects as assigned by the Vice Provost for Research and Research Integrity Director.
Assists Vice Provost for Research in ensuring research is conducted responsibly and uniformly throughout the Institution.
Analysis and Training:
The goal of the following activities is to ensure high quality services for the University of Denver’s researchers and staff involved with human research subjects, animals and biological materials.
Works with committee chairs, members, researchers and department/college administrators to integrate the regulations and ethical principles essential to the ethical conduct of research. Conducts quality and assurance reports for management.
Oversees the analysis and creation of reports that tracks compliance issues related to federal and university requirements.
Provides ongoing guidance regarding policy updates and identified deficiencies; updates policies; and provides support for the Office of Research Integrity and Education.
Provides education and guidance to investigators including review and/or preparation of study documents and corrective action plans; reviews regulatory requirements for documentation of study records, proper data security methods, and adherence to research and university policies.
Performs other duties and responsibilities as assigned.
Knowledge, Skills and Abilities
Computer proficiency, report writing, group management, organization and research regulations.
Ability to maintain confidentiality when exposed regularly to highly sensitive issues and uphold ethical practices amid complicated situations.
Demonstrated strong written and oral communication skills and ability to initiate and compose correspondence to investigators, department and college administrators and to Vice Provost of Research and to produce accurate written reports of research audits.
Demonstrated working knowledge of social behavioral and biomedical research terminology, and familiarity with animal welfare laws and of the NIH Guidelines for Research Involving Recombinant DNA Molecules.
Ability to work independently and as part of a team in a fast paced environment.
Possess exemplary interpersonal and time management skills.
Ability to communicate clearly in writing, in person, and by telephone.
Demonstrated characteristics: adaptability, agility, coaching, collaboration, collegiality, customer focus, ethics and integrity, judgment, and multi-tasking.
Ability to assert her or himself appropriately in meetings and in other contexts in order to represent the Office of Research and Sponsored Programs (ORSP), the policies and procedures of the Office of Research Integrity and Education, and the federal, state, and local regulations and guidance pertaining to human subject protections, animal welfare and biosafety.
CIP and/or CIM eligible
5+ years of demonstrated knowledge of federal, state, and local regulations governing the participation of human subjects in research, with familiarity of animal welfare and biosafety regulations through a role as an auditor or research monitor.
Bachelor’s Degree in Biological Studies, Public Health or related
In-depth knowledge of government and institutional regulations, in order to understand and explain the reasons for the requirements and the necessity to comply with any audit findings.
Monday – Friday, 8:00 a.m. – 4:30 p.m.
For best consideration, please submit your application materials by 4:00 p.m. (MST) February 7, 2019
Candidates must apply online through www.du.edu/jobs to be considered. Only applications submitted online will be accepted. Once within the job description online, please scroll to the bottom of the page to apply.
Please include the following documents with your application:
NOTE: The online system is limited to uploading 10 files. Please combine content if necessary to get all content uploaded.
The University of Denver is committed to enhancing the diversity of its faculty and staff. We are an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity, disability, military/ veteran status or any other status protected by law.
All offers of employment are based upon satisfactory completion of a criminal history background check.
Internal Number: 006088
About University of Denver
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 more than 100 undergraduate programs of study and more than 120 graduate and professional programs.
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