Human Subjects Protection Program Manager - Metropolitan State University of Denver in Denver Colorado

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Metropolitan State University of Denver

Denver, Colorado 80217

United States


Detailed Job Description

Under the general supervision of the Associate Vice President of Curriculum and Academic Effectiveness, who serves as the designated Institutional Official (IO) on MSU Denver’s Federalwide Assurance, the Manager is responsible for the Human Subjects Protection Program (HSPP) and Institutional Review Board (IRB) administration.
The HSPP Manager fulfills federal mandates to ensure a regulatory complaint research program to protect the public’s welfare, to ensure consistency and transparency at the institution in the oversight of human subjects research, and to protect the rights and welfare of research participants. Failure of the HSPP administration and/or IRB oversight can endanger the rights and welfare of research subjects and others, which can result in the stoppage of federally funded research, imposition of significant fines or civil or criminal penalties, and damage to the University’s reputation and standing in the academic and local community. In turn, this could significantly jeopardize future funding, faculty recruitment, and national standing.
The Manager will provide experience and knowledge to the HSPP and the IRB in order to establish a collaborative relationship with MSU Denver’s research community to ensure that research with human subjects is conducted in accordance with legal requirements, University standards, and the ethical principles of Respect for Persons, Beneficence, and Justice.

The candidate must have the ability to work with and be sensitive to the educational needs of a culturally diverse urban population. Metropolitan State University of Denver is an equal opportunity employer.


Operations and Support (70%)
• Manage all aspects of HSPP operations and IRB administration in compliance with federal, state, and local regulations and University policies involving human research and oversight.
• Enforce and follow written HSPP policies and procedures, which include conducting pre-reviews of submissions and making determinations of not human research and exemptions.
• Provide expertise to enhance program resources and the IRB review process in both efficiency and efficacy.
• Assist researchers in successfully navigating the IRB review process for new studies, amendments, continuing reviews, closures, and reportable information. Maintain the IRB webpages and manage online human research training.
• Serve as the liaison between the IRB and University faculty, staff and student researchers, sending IRB correspondence and facilitating IRB submission and review processes
• Maintain and update HSPP records system, including online and shared network drive document management and web-based protocol management systems, in accordance with institutional standards and federal requirements for confidentiality and records retention.
• Collaborate with the IO and fiscal manager(s) to develop the HSPP budget and ensure accountability for program expenditures.
• Serve as an alternate voting member of the MSU Denver IRB roster.
• Work collaboratively with the IO to ensure a diverse IRB roster that meets the needs of the regulatory requirements and the MSU Denver research community. Identify areas of expertise required for the Board and ensure representation of non-scientific and unaffiliated (community) members.
• Perform other duties as assigned in consultation with the Associate Vice President of Curriculum and Academic Effectiveness.

Communication and Compliance (20%)
• Monitor HSPP/IRB operations metrics, regulatory changes, and current interpretations and guidance relevant to human subjects protection. Provide updates and reports to the IRB, IO, and the University administration.
• Recommend adaptations in current programs, policies, and procedures to remain consistent with needs of researchers at the University and the regulatory requirements. Coordinate resources and implement changes accordingly.
• Perform quality assurance monitoring of HSPP and IRB activities, including (but not limited to) internal audits of review documentation and procedures, post-approval monitoring of research protocols, and investigations into matters of non-compliance. Develop and implement corrective actions(s), as needed, in collaboration with the IO and IRB in accordance with federal regulations and institutional policies and procedures.
• Promote understanding and adherence of relevant regulatory requirements and institutional standards by HSPP staff, IRB members, researchers, and administration.
• Liaise with University offices, programs, and departments involved in funding, reviewing, and conducting research to ensure coordination and enhance communication on research activities and oversight.
• Represent HSPP/IRB functions in University-wide research initiatives and serve as the institutional point-of-contact for program operations.
• Report to University officials, research sponsors, and appropriate federal agencies any allegations of noncompliance, harm, and/or risks to human subjects in accordance with relevant institutional, federal, and state regulations and policies.

Professional Development (10%)
• Develop, identify, and/or facilitate continuing education and professional development activities for IRB members and HSPP staff.

Required Qualifications

Bachelors degree with at least four years of experience working in Human Subjects Protection.

• Current certification as an IRB Professional (CIP) (or must obtain this certification within one year of employment).
• At least three years of research and/or research oversight experience in an institution of higher education or an organization with federal regulatory requirements for research, such as a government entity or hospital.
• Experience applying state and federal laws, regulations and guidelines in the area of human subjects protections.
• Experience working in collaboration with a broad spectrum of stakeholders, including students, faculty members, high level administrators, federal and state leaders, regulators, and sponsor representatives.
• Experience establishing data integrity and conducting data analysis.

• At least three years of experience working with Microsoft Office Suite ( Word, Excel, Power Point, Access, and Outlook).

Preferred Qualifications

• Master’s degree from an accredited institution of higher education and/or an equivalent combination of education and experience.
• Experience with web-based document management systems (IRBNet or similar) for handling and archiving confidential IRB submissions and review documentation.
• Prior experience as an IRB member, preferably in the review of both social-behavioral and biomedical research.
• Prior experience as a researcher (primary investigator, study coordinator, study administrator, etc.), preferably in the conduct of both social-behavioral and biomedical research.
• Understanding of the regulatory requirements for special populations and specialized research methods – e.g., research with vulnerable populations (children, prisoners, pregnant women, etc.); research involving Protected Health Information (PHI); community-based participatory research (CBPR); education research; Scholarship of Teaching and Learning (SoTL) research; international research; and/or multi-site studies.
• Experience in managing program or project budgets and expenses.
• Ability to work independently, handle matters confidentially, solve problems, and make decisions appropriate to the position.

Special Instructions to Applicants

IMPORTANT: in order to be considered as applicant YOU MUST FILL OUT THE APPLICATION AT Official Transcripts will be required of the candidate selected for hire.

Please Note: References refers to a list of names and contact information of three professional references.

Keyword Phrases

  • ASA / AC&C - Acad & Civic Collaboration
  • Human Subjects Protection Program Manager
  • Diverse institution
  • Urban environment
  • Comprehensive college offering bachelors & masters
  • Assessment, Accreditation, and Compliance
  • Legal Affairs
  • Sponsored Programs, Grants, and Contracts
Employment Type:Administrative Staff
Degree Required: Bachelors
Experience: See Job Description
Level of Job: Manager
Salary: Not Specified
Type of School:4 - Year / Masters Institution
Application Requirements: CV/Resume
Cover Letter