Job Description

The Regulatory Affairs Coordinator will provide administrative assistance to the Executive Director of Regulatory Affairs and the Assistant Director of Assurance Committees within Research Administration. The department of Regulatory Affairs provides oversight of the Institutional Review Board (IRB) for research involving human subjects; Research Integrity; Export Controls; the Assurance Committees for Animal Care, Biosafety, Radiation Safety, Radioactive Drug and Research Committee, and the Biosafety Level 3 Subcommittee. The coordinator will function as the point of contact for faculty and staff in need of assistance in the above-mentioned areas. The incumbent will be responsible for handling confidential and time-sensitive material. Compliance with University policies and procedures, other medical school departments, University Administration and affiliated institutions is required. The incumbent will be directly supervised by the Executive Director of Regulatory Affairs and will work closely with the Assistant Director of the Assurance Committees to provide daily support.

Our institution is committed to providing opportunities for advancement. The Coordinator for Regulatory Affairs is an entry-level position. Opportunities for advancement to a Project Coordinator and Project Manager may be available. Promotion is based on the demonstration of work that reflects increased complexity, quality work with decreased errors, and the ability to work with minimal supervision. Years of experience and professional development are also factors in determining promotion to higher levels.

Regular attendance is required to perform the functions of this position.

Incumbent will maintain a customer-oriented awareness in acknowledging and responding to needs as they occur that customer satisfaction is met at all times.

Essential Functions & Responsibilities:

70% Assurance Committee Responsibilities:

Provide support to the Assistant Director of Assurance Committees for animal and nonanimal research Institutional Animal Care and Use Committee (ACUC) Institutional Biosafety Committee Radiation Safety Committee Radioactive Drug and Research Committee (RDRC) Biosafety Level 3 Subcommittee (BSL3)

Below is a list of responsibilities of the Assistant Director of Assurance Committees; the Coordinator will not necessarily perform all of these duties but provide support as guided by both the Assistant Director and the Executive Director:

Review of the initial protocol submission (ACUC, Biosafety, RSC, BSL3, & RDRC) from primary investigator(s). Notifies all committee members that the agenda for the upcoming meeting is in the LSUHS File Sharing System and is ready for their review. Notifies all committee members of the respective committees of the next committee meeting. Schedules meeting rooms for all committee meetings. Creates and publishes a yearly calendar for each committee noting initial protocol submission deadlines, final protocol deadlines, and dates of committee meetings. Processes protocol addenda requests, terminations, addition/deletions of laboratory personnel for respective Assurance Committees. Composes an addendum history for all addenda to animal protocols. Maintains an "addendum tracker" for all addenda to ensure review and expedite approval. Maintains a reviewer data base for all protocol and all addenda to make sure the reviewer load is evenly distributed. Maintains databases for all assurance protocols, and addenda (ACUC, IBC, RSC, BSL3, & RDRC). Acknowledges receipt of all forms (protocol and addendum) to PI once received. Distributes to the ACUC members DMR questions, the Designated Member Review process for addenda and protocols after a Full Committee Review. Coordinates review of all addenda. Coordinates risk assessment of all addenda. Coordinates final approval notices of all addenda. After review and approval of PI responses, generates a final approval form and distributes to veterinarian and chair for signature (ACUC). This procedure is followed for all Assurance Committees (IBC, RSD, and RDRC). Track and maintain ACUC, Biosafety, and Radiation protocols in accordance with institutional oversight and for state and federal policies and procedures. Administer and facilitate required web-based education through Collaborative Institutional Training Initiative (CITI) training program for animal use in research, biosafety, and radiation safety. Maintain files and confidential documents for assurance committees and programs. Assists with the development of new committee policies and procedures based on federal and institutional guidelines. Submits policies to the respective committees for approval by a quorum of voting members. Formulate and transcribe detailed meeting Minutes for all the Assurance Committees meetings (regular, emergency, ad hoc, etc.). Takes notes at all committee meetings of additional questions/concerns about each protocol considered. Create monthly reports for collective ACUC research requested modifications required for assurance committee review to secure approval via Designated Member Review (DMR) and/or Full Committee Review (FCR), and Veterinary Verification and Consultation (VVC). Create and notify investigators of reports for monthly terminating/expiring protocols. Help coordinate the LSUHSC-S Semi-Annual ACUC program review and facility inspections (required for Office of Laboratory Animal Welfare Assurance/NIH), and all AAALAC accreditation meetings. Coordinated in collaboration with ACUC Chairperson and The Executive Director of Animal Resources. Help coordinate with USDA Veterinary Medical Official and LSUHS-Shreveport Animal Resources for annual institutional site inspection.

30% Regulatory Affairs Responsibilities:

Provide administrative assistance in collecting requested information from various stakeholders and organizing it thoughtfully. Provide administrative assistance in formatting and submitting Regulatory Affairs policy revisions and updates. Schedule meetings and book meeting rooms. Provide other administrative assistance to the Executive Director of Regulatory Affairs as needed; this includes providing support to the IRB and Export Control team members.

Qualifications

The applicant must meet the following:

Bachelor's Degree from an accredited university and two (2) years of professional experience. Strong attention to details. High proficiency in computer skills and knowledge of Microsoft Suite. Ability to work well in a team environment and handle multiple assignments. Must be able to work with diverse groups and individuals.

Preferred Qualifications

One or more years of experience in biology, animal science, or IACUC-related work. Familiarity with university animal research protocols and IACUC procedures.

Additional Position Information

PSN/PER Number:

PSN 59489/PER 2072/ATS 5749

Salary Range:

$45,000 - $55,000

Primary Location:

Shreveport, LA (on-site position)

About the School

The LSU Systems Office has provided LSU Health-Shreveport employees with excellent benefit options designed with you and your dependents in mind. Our Benefits Section is available between 8:00 a.m. and 4:30 p.m., Monday through Friday, to help answer any questions you might have about these benefits.

Salary is commensurate with experience and training Generous Health, Dental, and Vision Insurance Life Insurance Long-Term Disability Insurance Accidental Death & Dismemberment Insurance Flexible Spending Account Optional Retirement Plans

LSU Health is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Applicant Instructions

Locate and click on the Apply Online button located at the bottom of the screen, enter your contact information, and upload your resume/CV. If you need assistance applying electronically, please telephone 318-675-5589.

If you are contacted for an interview, please let us know at that time if you will need special accommodations.

Job Type: Full-time

Pay: $45,000.00 - $55,000.00 per year

Work Location: In person