The Institutional Biosafety Committee (IBC) Research Protocol Consultant reports to the Associate Director, Office of Responsible Research Practices, and is responsible for leading the administrative, regulatory, and programmatic activities supporting the university’s biosafety programs; establishing and maintaining efficient and compliant operational systems that facilitate review of instructional and research activities involving hazardous materials; developing a quality improvement program to monitor research compliance with federal regulations, agency guidance, state laws, and university policies for research involving biohazards; collaborating with other university leaders to promote best practices; directing related educational programming for university researchers, IBC members, and staff; collaborating with the Environmental Health and Safety (EHS) program to ensure appropriate biosafety oversight; preparing noncompliance and regulatory reports for review by the IBC chair; and assisting the Associate Director with strategic planning. Provides oversight and supervision to the IBC and support staff; works closely with HR and leadership on employee labor relations concerns; oversees and manages the recruitment, onboarding and training of new staff; performs additional duties as assigned.
IBC Committee Processes: prescreens IBC protocols for completeness and to ensure conformance with applicable federal and institutional requirements including ancillary committee reviews, conflict of interest disclosures, training requirements, and university research policies; oversees the recruitment and onboarding of IBC members; assigns protocols to reviewers; prepares meeting agendas, attends IBC meetings, and oversees the preparation of meeting minutes; collaborates with unit leaders and coordinates projects that span multiple units including ERIK leadership, Office of Research Integrity and Investigations, Office of Sponsored Programs, Office of Environmental Health and Safety, and Office of the Attending Veterinarian. Prepares regulatory documentation related to compliance matters.
Supervises staff, develops reports and analyzes metrics to manage Committee workflow; continually monitors timelines; identifies and implements customer service solutions; establishes, manages, and performs quality improvement monitoring of IBC projects; works with ERIK/OR education office to develop educational materials in support of IBC activities. Oversees and manages the recruitment, onboarding and training of new staff.
Manages the development of IBC policies and standard operating procedures and maintains the document repository; prepares and maintains records (e.g., rosters) and IBC correspondence; assists the university in complying with public records requests; prepares annual IBC chair/vice chair/member evaluations for the institutional official (IO); assists leadership with strategic planning.
Serves as the NIH point of contact for noncompliance, incident reports, and biohazard reports; fulfills record requests (NIH, CDC, APHIS); serves as point of contact for IBC matters that require OLAW, FDA, USDA, DOD or other regulatory oversight. Coordinates on these matters with the IO and/or the associate vice president for research integrity and investigations, as appropriate.
Maintains knowledge of governing regulations, university policies, and best practices; fosters a work environment emphasizing excellence, collaboration, integrity, trust, and diversity; and maintains sensitive and confidential information.
Required Qualifications:
- Bachelor’s degree in biological sciences (or related field) or equivalent combination of education and experience;
- 6 years of relevant experience;
- 2 years of working experience in biosafety research;
- 2 years of managerial experience;
- 1 year of experience in a research administrative capacity; demonstrated excellence in interpersonal and written communication skills.
Desired Qualifications:
- Master’s degree in biological sciences (or related field) or equivalent combination of education and experience;
- 8-12 years of relevant experience;
- 5 years of working experience in biosafety research;
- Certified Professional Biosafety Compliance Administrator (CPBCA);
- In-depth knowledge of federal regulations pertaining to research with biological materials; knowledge of the NIH biosafety assessment tool.
We strongly encourage that applicants submit both a resume and a cover letter.
Additional Information:
The pay range for this job profile is $74,900 – 98,500. The offer for this position will fall within this range based on multiple factors including internal equity, unit’s available budget, and the candidate’s qualifications.
Employees are provided several flexible work schedule and location options aligned with U.S. Eastern Time Zone including an option for remote. All employees are provided university-configured equipment and supportive technology tools. Employees are required to provide reliable internet access and home office furnishings for approved remote work locations.
Function: Research Administration
Sub-function: Research Protocol
Career Level: S4
