Director of Human Research Protection Program

Virginia Tech - Blacksburg, VA (30+ days ago)4.4

Full-timeEstimated: $84,000 - $110,000 a year

EducationSkills
The mission of Virginia Tech’s Office of the Vice President for Research and Innovation (OVPRI) is to support university-wide strategic initiatives and operational functions of Virginia Tech’s $520+ million research enterprise and associated technology commercialization activities, which span nine academic colleges, eight university research institutes, and three affiliated corporations. The Scholarly Integrity and Research Compliance (SIRC) office within OVPRI is responsible for oversight and management of research regulatory compliance committees, ensuring ethical excellence and compliance with applicable policies, standards, and regulations. With the continual growth in Virginia Tech’s research portfolio, the Director of the Human Research Protection Program (HRPP) is a key position in supporting the ambitious plans for Virginia Tech to be a leading 21st century land grant university that delivers innovative solutions to the most pressing global challenges of our time.

About Scholarly Integrity and Research Compliance:
Deeply committed to the highest ethical standards in scholarship, and to proactive advancement of basic, translational, and transformative scientific advancement for the improvement of the human condition and world, Virginia Tech’s office of Scholarly Integrity and Research Compliance facilitates scholarly excellence by ensuring research regulatory compliance and facilitating ethical decision making. Five teams ensure protection of human participants and animal subjects, as well as environmental and personnel safety of laboratory research. Virginia Tech’s Human Research Protection Program conducts critical tasks within the SIRC, which is led by the Associate Vice President, who in turn reports to the Vice President for Research and Innovation.

Position Summary:
The Director of HRPP assumes a critical role in the research enterprise at Virginia Tech. The incumbent’s primary responsibilities are to ensure that all aspects of human subject research conducted under the university’s auspices are carried out in such a manner that the rights and welfare of participants in research are protected and that Virginia Tech is in compliance with institutional, state, local, and federal regulations. Specific responsibilities include 1) management and supervision of experienced staff that provides administrative and regulatory support to VT IRB, 2) coordination with other divisions and units responsible for implementing other aspects of human research protection programs and initiatives, 3) providing subject matter-specific counsel to HRPP team members, Board members, and investigators, 4) proactively creating and/or revising, as necessary, VT-specific policy and corresponding guidance to assure consistency and currency with best practices and evolving external policies such as NIH’s sIRB Policy and Common Rule revisions, and 5) advising and briefing the AVP for Scholarly Integrity and Research Compliance regarding all matters significantly impacting either the IRB in specific or the broader, institution-wide, network of human subject protection entities, activities, and initiatives.

Opportunities
  • Grow the HSPP program and resources
  • Build and lead an HRPP team reflective of the incumbent’s vision
  • Lead efforts for AAHRPP accreditation
Core Responsibilities
  • Lead strategic and operational initiatives of VT’s HRPP (50%)
o Manage activities of the HRPP team
o Serve as IRB Administrator, providing comprehensive support to the VT IRB, including recruitment, orientation, training and regulatory guidance to Board members
o Develop and implement strategic, operational, and tactical plans and procedures to achieve goals and objectives
o Prepare VT’s HRPP for AAHRPP accreditation
o Lead and direct HRPP and IRB operations through all phases of the study lifecycle
o Lead development and use of standards, tools, and metrics
o Lead and coordinate process and quality improvement initiatives in partnership with leadership; consult with SMEs, as appropriate
o Lead and mentor HRPP staff comprised of administrative and regulatory specialists, and protocol coordinators
o Project and manage protocol submission queue to ensure thorough, timely, and efficient review of protocols from submission to final determination, post-approval monitoring, and completion
o Develop and document standard procedures for the HRPP team to receive, organize, and archive files related to protocols, committee actions, and correspondence, such that individual items can be readily retrieved and are filed in accordance with appropriate security and regulatory standards
o Receive, process, redirect as appropriate, and archive incoming correspondence, maintaining organized and accessible electronic copies of all incoming and outgoing official correspondence
o Collaborate with the IRB Chair and AVP of the SIRC to ensure fully documented compliance with all applicable laws, rules, regulations, and policies governing inclusion of human subjects in research, and other areas as directed
o Ensure protocols pre-reviewed by HRPP analysts are sufficiently complete to be forwarded to the IRB for action
o In unique or challenging situations, provide consultation and guidance to HRPP staff and IRB Chair Designee reviewers
o Oversee HRPP review of grant proposals for federally funded, non-exempt protocols to confirm and document consistency between the proposal’s protocol language and the content of the of the protocol submitted to the IRB

  • Engage the VT community to promote ethical excellence in research with human participants (35%)
o Collaborate and work cross-functionally to obtain input on all facets of HRPP interactions with other institutional offices and divisions
o Provide comprehensive support to the VT investigator community engaged in human subjects research, teaching, or other scholarly activities
o Establish and maintain open communication with investigator population served by VT HRPP and IRB, soliciting real-time feedback on IRB performance
o Provide superior customer service to all clients with inquiries, issues, or needs
o Develop and support HRPP- and IRB-related cooperative relationships with internal and external consultants and collaborators, such as external privacy/security and commercial IRB consultants, single IRB collaborators, and internal legal counsel, information technology divisions, and others
o Provide guidance to principal investigators and research team members to assist with the preparation of high quality initial IRB application submissions, consistent with laws, regulations, policies, and best practices
o Ensure currency and user-friendliness of the HRPP and IRB website
o Advise and report regularly to AVP for Scholarly Integrity and Research Compliance, keeping her/him apprised of status of major IRB strategic and operational goals and objectives, best practices and corresponding implementation options, and emerging needs or challenges that could adversely impact efficient delivery of high-quality human subjects protection services

  • Interface with federal, state, and local officials, and other external agencies to ensure transparent implementation of research regulations (10%)
o Stay abreast of changes in federal and state regulations and guidance, and develop corresponding policy and implementation plans to ensure compliance
o Coordinate development of, and maintain materials required for, review, inspection, or audit by federal, state or local officials; generate reports for internal and external authorities
o Assess sufficiency of written agreements between VT and collaborating institutions, ensure adequate oversight of such agreements
o Maintain university registrations with federal regulatory agencies and provide leadership when reports or site visits by inspectors or auditors are required, whether from internal or external entities

  • Implement other related duties as assigned (5%)
Required Qualifications:
  • Master’s degree or bachelor’s degree with equivalent advanced experience
  • Demonstrated progressively advanced experience working in an AAHRPP-accredited entity, or current working knowledge of HRPP operations under AAHRPP accreditation
  • Certified IRB Professional (CIP) in good standing, or the ability to obtain CIP within 12 months
  • Current CITI training certification
  • General knowledge of regulatory mandates and other human subject protection programs and objectives related to sIRB policy, Common Rule, ClinicalTrials.gov, SmartIRB, etc.
Preferred Qualifications:
  • Significant experience leading one or more HRPP administrative teams at an AAHRPP-accredited entity
  • Supervisory and leadership experience in a fast-paced, customer service-oriented setting
  • Experience with the process an entity follows to move from unaccredited to AAHRPP-accredited status
  • Thorough content and working knowledge of regulatory mandates and other human subject protection objectives related to sIRB policy, Common Rule, ClinicalTrials.gov, SmartIRB, etc.
Employment Conditions: Must have a conviction check: Yes Describe Other: Employment Comments: How to Apply for this Job:
For a full description of the position and requirements, and to apply, please go to www.jobs.vt.edu, posting #AP0180294. Attach a resume, cover letter, and list of three professional references to the online application. Review of applications will begin on September 25, 2018 and continue until the position is filled.

Employee Category: Administrative and Professional Faculty Appointment Type: Regular If restricted or temporary, enter end date: FLSA Status: Exempt: Not eligible for overtime Tenure Status: Non-Tenure Track Academic Year or Calendar Year: Calendar Year Percent Employment: Full-time If part time, enter Percent Time: Pay Range: Commensurate with Experience Location: Blacksburg Department: Research Compliance Location, if not Blacksburg: Location Zip Code: 24061 Work Schedule: M-F 8-5 Job Posting Date: 08/30/2018 Review Begin Date: 09/25/2018 Job Close Date: Restricted to university employees only? No Equal Opportunity/Affirmative Action Statement:
Virginia Tech does not discriminate against employees, students, or applicants on the basis of age, color, disability, sex (including pregnancy), gender, gender identity, gender expression, genetic information, national origin, political affiliation, race, religion, sexual orientation, or veteran status, or otherwise discriminate against employees or applicants who inquire about, discuss, or disclose their compensation or the compensation of other employees or applicants, or on any other basis protected by law.

Reasonable Accommodation Statement:
If you are an individual with a disability and desire accommodation please contact the hiring department.