Employment Type : Full-Time
Overview: The Regulatory Affairs Specialist (RAS) is expected to have excellent problem-solving, critical thinking, negotiation, and teamwork skills as well as excellent written and verbal communication skills. A successful candidate should be organized, able to multi-task, maintain a positive, helpful attitude, and take direction from Regulatory Affairs Manager (RAM). This position supports faculty who submit applications to FDA to obtain permission to study investigational drugs, biologics, and medical devices.
The primary tasks include preparation, submission, and maintenance of regulatory documents required for UAMS-sponsored IND/IDE applications and files. Applicants will be expected to assist with review of clinical research protocols, assuring that content meets the requirements of the U.S. Food and Drug Administration (FDA) and the UAMS Institutional Review Board (IRB). This position will require applicants to coordinate activities of investigators, other Office of Research Regulatory Affairs (ORRA) staff, and ancillary staff to achieve rapid and accurate project completion, meet deadlines and deliver detailed written reports as necessary.
In addition to initial FDA submissions, the RAS must understand pertinent regulations, manage adverse event reporting, handle annual reports, coordinate communication with FDA, and apply pertinent federal regulations to individual research proposals. The successful applicant will be expected to prepare and provide presentations; assist in the development of forms, templates, and project-specific documents; assist in the development of policies and procedures pertaining to regulatory matters and internal procedures.
The University of Arkansas for Medical Sciences (UAMS) has a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity. We champion being a collaborative health care organization, focused on improving the health, health care, and well-being of Arkansans.
UAMS offers amazing benefits and perks:
Salary: offered commensurate with experienceResponsibilities:Responsibilities for the Regulatory Affairs Specialist I:Level I:The Regulatory Affairs Specialist (RAS I) will be trained to apply relevant parts of the Code of Federal Regulations (21 CFR 312, 21 CFR 812, etc.) to prepare documents for initial FDA submissions as well as subsequent filings including but not limited to modified protocols, consent forms, IND safety reports, serious adverse events (SAEs), unanticipated device adverse effects (UADE), and annual progress reports (APRs). Primary job functions do not typically require exercising independent judgment (as proficiency increases, a more independent approach is determined).
Qualifications:Minimum Qualifications:
Level I:
Special knowledge, abilities and skills:
Preferred Qualifications:
Level I:
Special knowledge, abilities and skills:
Level I:
UAMS is an Affirmative Action and Equal Opportunity Employer of individuals with disabilities and protected veterans and is committed to excellence. If you need a reasonable accommodation for any part of the employment process, please contact us by telephone at (501) 686-6432 and let us know the nature of your request. We will only respond to messages left that involve a request for a reasonable accommodation in the application process. We will accommodate the needs of any qualified candidate who requests a reasonable accommodation under the Americans with Disabilities Act (ADA).Physical Requirements: Stand: Occasionally
Sit: Frequently
Walk: Occasionally
Bend, crawl, crouch, kneel, stoop, or reach overhead: Occasionally
Lift, push, pull, carry weight: 11 - 25 lbs
Use hands to touch, handle, or feel: Occasionally
Talk: Frequently
Hear: Frequently
Taste or smell: Never
Read, concentrate, think analytically: Continuously
Physical Environment: Inside Office Environment
Noise Level: Quiet
Visual Requirements: Depth perception, Far visual acuity, Near visual acuity
Hazards: None