Request to Recruit
| Position Title |
Associate Director of Research Protections |
| Location |
Boone, NC |
| Faculty Rank |
No |
| Provide Rank |
|
| Position Number |
0A0151 |
| Department |
Office of Research and Innovation- 282000 |
Position Summary Information
| Minimum Qualifications |
- Bachelor's Degree from an accredited institution
- At least five years of prior experience within an IRB office or IRB Full Board that facilitates the approval of social-behavioral and some bio-medical research.
- At least two years of supervision, advising, or mentorship experience.
- Familiarity with and understanding of federal regulations and agency guidelines for human subjects research, including HHS, FDA, HIPAA, FERPA, NIH, NSF, etc.
- Ability to create and implement effective university policies, unit standards, and unit procedures.
- Ability to balance ethical considerations and regulatory requirements to practical situations.
- Critical thinking, flexibility of thought, and ability to synthesize information from multiple sources to produce succinct, detail-oriented, and accurate determinations, documents, and reports.
- Attention to detail and ability to identify small inconsistencies among a large amount of information.
- Demonstrated written and oral communication skills including the ability to communicate with a wide variety of staff, faculty, and non-faculty researchers at multiple skill levels and across multiple types of academic disciplines.
|
| License/Certification Required |
|
| Preferred Qualifications |
Preferred Qualifications
- Master's degree from an accredited institution where a research project involving human subjects was completed as part of the degree program or related assistantship such as a master's thesis, lab work, fieldwork, or a dissertation.
- At least 5 years of supervision, advising, or mentorship experience.
- Experience creating policy, program and/or process improvements in research compliance that include proactively engaging multiple stakeholders.
- Certified IRB Professional (CIP) Certification or the Certified IRB Manager (CIM) Certification.
|
| Essential Duties and Responsibilities |
The Office of Research and Innovation supports Appalachian State University's scholarly and creative activities by expanding access to and facilitating the management of research opportunities. The Office enhances the research enterprise by building capacity through research development and methodological and statistical consultation, providing support for externally funded projects, ensuring compliance for regulatory programs, and facilitating the protection, management, and translation of intellectual property. The Office of Research and Innovation also collaborates with Special Funds Accounting on the fiscal management of awarded projects. The Units within the Office of Research and Innovation include Research Protections, Sponsored Programs, Grants Resources and Services, and Research Design and Analysis.
The Office of Research Protections facilitates research and creative endeavors by administering programs that provide ethical and regulatory oversight of research involving human participants, animals, and recombinant
DNA. In addition, we are responsible for campus administration of export control regulations and the conflicts of interest policy. In support of the University's mission of transmitting and applying knowledge to address the needs of society, we facilitate the protection of intellectual property. The Office of Research Protections includes the following functional areas: the Institutional Review Board (
IRB), Responsible Conduct for Research (
RCR), Conflict of interest and Commitment (
COI), Export Controls (EC), Institutional Biosafety Council (
IBC), the Institutional Care and use Committee (
IACUC), and Intellectual Property (IP).
Essential Duties and Responsibilities of the Associate Director of Research Protections:
- Provide leadership for the development of the IRB office at App State including supervision of two mid level IRB Coordinators.
- Develop and maintain IRB office unit standards and all subsequent procedures to promote compliance with federal regulations and current best practices.
- Review and approve any research that meets the federal criteria for Exemption or Expedited review including initial reviews, amendments, continuing reviews, and "Just in Time" reviews.
- Manage the IRB review process for Full Board protocols, FDA regulated protocols, large or complex protocols, and funded protocols.
- Manage and facilitate the Post-Approval monitoring processes as appropriate.
- Identify, manage, and resolve instances of non-compliance in accordance with federal regulations and University policy in cooperation with the IRB Chair and/or IRB Full Board.
- Receive and reconcile reported issues of Unanticipated Problems and Adverse Events.
- Receive reconcile complaints from human subjects and resolve in accordance with University's policies and federal regulations.
- Facilitate "for cause" and random audits in accordance with App State IRB unit standards.
- Serve as the IO's signatory designee for Reliance agreements and Individual Authorization Agreements. In conjunction with the IRB Coordinator for Administration, determine when Institutional Authorization Agreements are appropriate.
- Recruit, assist in selection of, and train all IRB Full Board Members including the IRB Chair.
- Work closely with the IRB Chair regarding any issues related to human subjects' research.
- Attend IRB committee meetings to provide guidance for all reviews including advising board members on the criteria for approval and any FDA regulatory requirements.
- Serve as a primary voting member on the App State IRB Full Board.
- Participate in the hiring, training, and supervision of IRB personnel.
- Lead assessment efforts for IRB office effectiveness using a variety of metrics.
- Perform outreach and education activities with the research community at App State in conjunction with the IRB Coordinator for Ed and Outreach.
- Advise staff on the development and maintenance of web content and other electronic media content.
- Serve as lecturer, provide presentations, and serve on appropriate panels geared toward education and outreach regarding research.
- Engage App State and local partners in educational and outreach endeavors.
- Serve as liaison between App State and research-related federal agencies, regulators, organizations, or sponsoring agencies.
- Serve on University committees as an IRB representative for research-related university-level committees.
- Consult with related units at the University to facilitate compliant research at App State including but not limited to the Office of General Counsel, Sponsored Programs, and the COI office.
- Act as liaison between the IRB Office and University personnel, helping researchers understand and fulfill federal requirements.
- Manage Federal Wide Assurance and IRB Registration documentation.
- This position is also expected to perform job functions of all IRB staff should the need arise.
|
| Type of Position |
Full Time Position |
| Staff/Non-Faculty |
Staff/Non-Faculty |
| Appointment Type |
1.0 |
| Work Schedule/Hours |
Monday - Friday, 8 hours a weekday. Flexible work arrangement available including in office, remote, and flexible timeframe within the workweek |
| Number of Hours Per Week |
40 |
| Number of Months Per Year |
12 |
| Mandatory Staff |
No |
| Suggested Salary Range |
$82,000 - $94,000 |
| Physical Demands of Position |
To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential job functions. |
Posting Details Information
| Posting Date |
10/21/2024 |
| Closing Date |
11/14/2024 |
| Open Until Filled |
No |
| Evaluation of Applications Begins |
11/15/2024 |
| Proposed Date of Hire |
12/02/2024 |
| Special Instructions to Applicants |
Please attach required documents:
- Cover Letter
- Resume
- List a minimum of 3 professional references in the application or attach a List of References with contact information included
|
| Search Chair Name |
Shante Mathes |
| Search Chair Email |
mathessc@appstate.edu |
| Quick Link |
https://appstate.peopleadmin.com/postings/48403 |
| Posting Number |
201501515P |
|
Appalachian State University
Oct 22, 2024