Associate Director of Research Protections

Appalachian State University • Boone, NC

438d • $82,000 - $94,000

About The Position

The Associate Director of Research Protections at Appalachian State University plays a crucial role in overseeing the ethical and regulatory compliance of research involving human participants, animals, and recombinant DNA. This position involves leadership in the Institutional Review Board (IRB) office, ensuring adherence to federal regulations, and developing policies and procedures that promote compliance and best practices. The role also includes managing the IRB review process, supervising staff, and engaging with the research community to facilitate compliant research activities.

Requirements

• Bachelor's Degree from an accredited institution.
• At least five years of prior experience within an IRB office or IRB Full Board.
• At least two years of supervision, advising, or mentorship experience.
• Familiarity with federal regulations and agency guidelines for human subjects research (HHS, FDA, HIPAA, FERPA, NIH, NSF, etc.).
• Ability to create and implement effective university policies and procedures.
• Critical thinking and flexibility of thought to synthesize information from multiple sources.
• Attention to detail and ability to identify inconsistencies in information.
• Demonstrated written and oral communication skills.

Nice To Haves

• Master's degree from an accredited institution with a research project involving human subjects.
• At least 5 years of supervision, advising, or mentorship experience.
• Experience creating policy and process improvements in research compliance.
• Certified IRB Professional (CIP) Certification or Certified IRB Manager (CIM) Certification.

Responsibilities

• Provide leadership for the development of the IRB office, including supervision of two mid-level IRB Coordinators.
• Develop and maintain IRB office unit standards and procedures to promote compliance with federal regulations and best practices.
• Review and approve research that meets federal criteria for Exemption or Expedited review, including initial reviews, amendments, and continuing reviews.
• Manage the IRB review process for Full Board protocols, FDA regulated protocols, and complex funded protocols.
• Manage and facilitate Post-Approval monitoring processes as appropriate.
• Identify, manage, and resolve instances of non-compliance in accordance with federal regulations and University policy.
• Receive and reconcile reported issues of Unanticipated Problems and Adverse Events.
• Resolve complaints from human subjects in accordance with University policies and federal regulations.
• Facilitate audits in accordance with App State IRB unit standards.
• Serve as the IO's signatory designee for Reliance agreements and Individual Authorization Agreements.
• Recruit, assist in selection of, and train all IRB Full Board Members including the IRB Chair.
• Attend IRB committee meetings to provide guidance for reviews and advise board members on approval criteria and FDA regulatory requirements.
• Serve as 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 various metrics.
• Perform outreach and education activities with the research community at App State.
• Advise staff on the development and maintenance of web content and electronic media content.
• Serve as lecturer and provide presentations regarding research.
• Engage App State and local partners in educational and outreach endeavors.
• Serve as liaison between App State and research-related federal agencies and organizations.
• Serve on University committees as an IRB representative.
• Consult with related units at the University to facilitate compliant research.
• Manage Federal Wide Assurance and IRB Registration documentation.

Benefits

• Flexible work arrangement including in-office, remote, and flexible hours.
• Health insurance coverage.
• Retirement savings plan options.
• Paid holidays and vacation time.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Educational Services
• Education Level: Bachelor's degree