Under the direction of the IRB Chair, the IRB Administrator will be responsible for the day-to-day administrative management of the IRB. Assists in the identification of potential regulatory issues with human subjects research protocols, provides technical support and procedural guidance to Roseman staff. The IRB Administrator reviews human subject research proposal submissions for completeness and adherence with Roseman policies and procedures and federal regulations. Supporting all IRB related activities including protocol submissions, development of IRB related documents, and supporting the IRB members and the administrative team.
Duties and Responsibilities (Essential Functions)
Conduct comprehensive and timely review of all new submissions for appropriate level of review and submission completeness and conformance with established university, federal and state regulations.
Serve as consultant to members, investigators and key personnel on regulations and preparation of applications.
Educate and advise investigators and key personnel in response to submissions; recommend adaptations to ensure adequacy & completeness.
Provide support to the research community and staff on the web-based electronic submission system.
Monitor, evaluate and update IRB procedures in collaboration with IRB Chairs and Administrative Assistant
Recommend changes to IRB application forms and consent documents and staff checklists to improve IRB operations.
Assess educational needs of constituency and design appropriate resources and offerings
Maintain current understanding and knowledge of federal and state regulations, state and local laws.
Helps facilitate IRB Meetings.
Independently draft IRB minutes.
Regular attendance is an essential function on the job
Reliable and timely with an expectation of 40 hours per week on site.
May be required to perform other duties as assigned.
Knowledge, Skills and Abilities
Individual must possess the knowledge and following skills and abilities or be able to perform the essential functions of the job, with or without reasonable accommodation, using some other combination of skills and abilities:
Advanced computer skills, including proficiency in Microsoft Word, Outlook, and Excel.
Excellent professional business writing and oral communication skills.
Great attention to detail with the ability to stay organized and manage time appropriately with the ability manage multiple projects simultaneously.
Must be able to work independently and collaboratively as a team member.
Bachelor's degree in a scientific or health care field, or equivalent experience
Any combination of education and work experience that provides required knowledge, skills, and abilities deemed necessary for this position.
Detailed knowledge of federal regulations pertaining to research.
Strong knowledge of protocol processes and approval mechanisms included in ongoing oversight.
Communication and interpersonal skills needed to work closely and effectively with principal investigators, committee members and administrative personnel.
Strong written and oral communication skills.
Strong independent thinking and complex problem solving skills.
Ability to educate and conduct training sessions both on individual and group level
Experience in handling complex and confidential material
Working knowledge of MS Office products and comfortable learning new web-based platforms.
5 years of scientific research related experience; 1-2 years of experience in an academic health center or medical school IRB is strongly preferred
Experience using IRBNet submission software
Certification as an IRB professional
Required Physical Abilities
Ability to bend, stoop, reach, stand, move from one area of the building to another on a regular basis, sit and use a computer for a long period of time.
Manual and physical dexterity needed to operate a computer keyboard and handle paper documents.
Sufficient near vision acuity to read information appearing on computer display screen, hand-written forms, and printed on paper.
Adequate hearing and verbal abilities to communicate effectively in person and by telephone.
Ability to lift and carry a stack of forms and documents weighing up to 25 pounds.
Internal Number: SJ078
About Roseman University of Health Sciences
Founded in Henderson, Nevada in 1999, Roseman University of Health Sciences is a non-profit, private institution of higher learning training the next generation of undergraduate and graduate level health care professionals that serve, collaborate and set new standards in their communities and within their professions.