Associate Director, Human Research Protections Program and IRBs

Job location: Boca Raton


Employment Type: Full-time
Posted data: 2021-05-13
Req: REQ10158
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Position Summary:

Florida Atlantic University is seeking an Associate Director, Human Research Protections Program and IRBs, Boca Raton, FL.

With over 30,000 students from all 50 states and over 180 countries, 21 intercollegiate teams, 180 plus degree programs, and an administration that thrives on discovery and excellence, FAU is pushing the boundaries of higher education. Florida Atlantic's faculty and staff are trailblazers and innovators with a passion for finding creative solutions while advancing science, art, and technology in all disciplines. Our work environment is a hub of cultures from across the nation and the world, making FAU a place where collaboration flourishes.

The Associate Director, Human Research Protections Program and IRBs reports to the Assistant Vice President for Research, Research Integrity and is responsible for the Management, administration and control of activities of the human research protections program. They are responsible for the planning, directing, and reporting of activities and programs related to the human research protections program. In addition, the Associate Director develops and implements policies and procedures for the human research protections program. They may function for the Assistant VP in their absence through the delegated responsibility for the overall direction and management of Research Integrity and/or the human research protections program. In this role, the Associate Director performs related duties appropriate to the accomplishment of the responsibilities and functions of his/her area.

Summary of Responsibilities Include:

  • Primary responsibility for the management and administration of the Human Research Protections Program (HRPP) including the Social Behavioral and Educational Research (SBER) and the Health Sciences (HS) IRBs within the Research Integrity Unit.
  • Responsible for the supervision and coordination of the human research protections program personnel to assist, advise and guide faculty, students and staff with preparing protocols, reviewing protocols and identifying potential compliance issues.
  • Responsible for the day-to-day supervision of the human research protections program staff including (but not limited to), conducting annual performance reviews, review and approval of time off, and providing professional development opportunities.
  • Responsible for maintaining policies, and standard operating procedures (SOPs) updated, as well as the development and implementation of new policies, -and SOPs related to the effective management of the human research protections program including effectively communicating with FAU researchers.
  • Responsible for developing and maintaining metrics for the HRPP and IRBs.
  • Liaison with clinical sites, organizations, hospitals and partners for purposes of coordination and joint research endeavors in conjunction with Assistant VP.
  • Develop, implement and manage the HRPP Quality Improvement/Assurance Program.
  • Lead efforts in obtaining and sustaining AAHRPP accreditation of FAU’s HRPP.
  • Coordinate clinical trials and clinical research activities related to protection of human subjects, including CT.gov, IRB submission of clinical trials including regulatory requirements and expansion of resources within the Division of Research (DoR) and Florida Atlantic University (FAU) to facilitate study start up and commercial IRB approvals.
  • Develop and implement outreach-training programs educating faculty, staff and students on their regulatory compliance responsibilities and keeping them informed of updated information.
  • Develop, manage and expand needed content on the RI webpage.
  • Oversee the review and approval processes related to IRB submissions including screening, coordinating the review process, determining difficulty level of protocol issues, assists in preparation of protocol actions, assigns reviewers, delineates revision requirements, reviews investigators' responses, and elicits reviewers’ assistance.
  • Manage the gathering of information and background material in response to inquiries/issues raised related to non-compliance allegations, responds to requests for information regarding IRB oversight and makes applicable determinations.
  • Advise researchers, HRPP personnel and committee members regarding regulations, policies, procedures and guidelines for protocol applications, consent forms, related documents and regulatory requirements.
  • Has primary responsibility to the Assistant VP regarding issues raised by IRB committees or researchers.
  • Direction of office staff specific to IRBs in preparation of required IRB documents, including, but not limited to: meeting agendas and minutes, documentation memos, agreements, non-compliance reports and other related documentation.
  • Advise researchers regarding agreements needed to access sites and / or data use including data security.
  • Coordinate with Sponsored Programs and legal counsel regarding data use agreements, institutional authorization agreements, IRB reciprocity agreements and other agreements related to the collection and/ or use of research involving human subjects.
  • Responsible for streamlining communications and processes between Research Integrity (HRPP), Sponsored Programs and Research Accounting for grant congruency, regulatory compliance, account verification and set up.
  • Responsible for expanding and maintaining the necessary membership of the IRBs to satisfy the regulatory requirements, including coordinating and providing training opportunities of the members.
  • Manage regulatory compliance with the Office of Undergraduate Research and Inquiry for undergraduate research projects involving human subjects to enable the success of the FAU QEP program.
  • Manage and oversee electronic protocol management system through IRBNet or alternative electronic system.
  • Network with HRPPs around the country to share knowledge and experiences.
  • Performs other duties as assigned.

Minimum Qualifications:

Master's degree from an accredited institution in an appropriate area of specialization and five years of appropriate experience; or a bachelor's degree from an accredited institution in an appropriate area and eight years of appropriate experience required

Master's degree preferred.

Prior supervisory experience required.

Certified IRB Professional (CIP) or willingness to become a CIP within a year of hiring required.

Salary:

$80,000 - $95,000

College or Department:

Division of Research

Location:

Boca Raton

Work Days and Hours:

Monday – Friday, 8 a.m. – 5 p.m.

Application Deadline:

2021-05-27-07:00

Special Instructions to Applicant:

Individuals with disabilities requiring accommodation, please call 561-297-3057. 711

Final candidate will be required to have official, sealed transcripts and original NACES evaluation, if applicable, sent from their educational institution to Human Resources prior to the start of employment.

Successful completion of a background check, which may include a motor vehicle check, credit check, fingerprinting or additional screening, is required for the selected candidate prior to the start date.

A resume and a cover letter are required for this position. Make sure to attach these required documents in the Attachments section of the application. Any missing required documents may result in disqualification.

This recruitment has been reopened; all previous applicants are still under consideration and need not reapply. This position may close without prior notice.

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