Research Compliance Specialist

Provides customer assistance and support to one or more of the functional areas within the Office of Research Compliance by processing new protocols, coordinating and managing the review process, determining level of review and supporting the protocol or disclosure oversight/reporting processes to ensure compliance with all applicable university, sponsor, ABOR, state and federal requirements, standards and regulations. Essential Duties

• Acts as administrative resource to ASU researchers and staff to provide assistance, and guidance during development, pre-submission administrative review, management, authorization and submissions of protocols for review and approval.
• Consults with staff, faculty and others to provide technical advice, problem solving assistance, and answer questions about area of assignment to ensure ongoing compliance with all applicable regulatory controls including, but not limited to: sponsor, ABOR, university, state and federal regulations
• Coordinates meetings, prepares agenda and material to meet distribution deadlines; performs follow up as needed. Records meeting activities, discussions, agreements and outcomes. Responds to questions raised during committee meetings on an as-needed basis; researches information as appropriate/needed as follow up.
• Monitors and conducts review of existing and new protocols. Assists with reviewing and implementation of forms, policies and standard operating procedures needed. Investigates, interprets and provides guidance to faculty and staff on regulations related to area of assignment.
• Identifies area of focus for education topics and provides outreach training/workshops/seminars for the University community on policies, procedures, system enhancements for area of assignment.
• Informs IRB Manager and Associate Director of issues raised by regulatory committee or investigators. Maintains all applicable protocol records and files. Provides solutions to problems and recommends changes to methods or procedures to management, utilizing knowledge of best practices and principles.
• Develops and prepares routine area specific reports and contributes to department information gathering initiatives as they arise. Performs other duties as assigned. Actual job responsibilities may vary depending upon area assignment.
• Meets and adheres to timelines and guidelines for responding to inquires and reviews.

Desired Qualifications This is an entry level position but candidates with 2-5 years experience will be considered. This position is with Research Integrity and Assurance within Office of Research Compliance and under close supervision and direction supports one functional area including, but not limited to:

• Human subject protections
• Animal care and use, biosafety
• Financial conflicts of interest
• Misconduct in research
• Outreach programs related to regulatory compliance
• Follows standard practices and procedures in analyzing information from which answers can be readily determined.

Key Skills:

• Team-oriented
• Able to effectively respond to routine situations involving potentially several university constituencies
• Able to follow directions set by unit and/or supervisor
• Ability to provide ideas and recommendations to resolve routine issues
• Has general understanding of requirements for assigned responsibilities
• Works with supervisor to prioritize and manage time
• Good collegial interpersonal skills and an ability to communicate effectively in person, writing, and by phone
• Skill in establishing and maintaining effective professional working relationships
• Refers issues to more senior staff and/or supervisor for guidance
• May assist with data gathering and initial analysis under direction of more senior staff member
• Supports a customer group and works with other internal university contacts

Bachelor's degree and three years of related experience or any equivalent combination of experience, and/or education from which comparable knowledge, skills and abilities have been achieved is desired. Working Environment

• Climate-controlled office setting subject to extended periods of being in a stationary position.
• Regular use of a computer and other office productivity equipment, such as a calculator, copy machine and printer.
• Ability to clearly communicate and exchange accurate information to perform essential duties.
• Ability to interpret complex state and federal regulations.
• Expected to be responsive to customers; engaged in work production; and resourceful, flexible, and respectful of others.
• Ability to work effectively within a complex structured team.
• Works under supervision; receives detailed instructions and works from general instructions on standard job duties.
• Regular review of completed tasks may be required.

Department Statement: Research Integrity and Assurance (RIA) was established as a resource for investigators and the university to achieve and maintain ethical principles and compliance with federal, state, and university regulations governing research. RIA’s mission is to 1) Provide education and outreach on compliance areas 2) Utilize efficient processes to make compliance as easy as possible for the regulated community 3) Support institutional compliance committees. The Institutional Review Board (IRB) is one compliance area and the IRB reviews all proposed research involving human subjects to ensure that the subjects are treated ethically and that their rights and welfare are adequately protected. ASU Knowledge Enterprise advances research, innovation, strategic partnerships, entrepreneurship, and international development. Our success arises from solutions focused, interdisciplinary research; an entrepreneurial approach that is embedded in every school and department; and a commitment to transform society in a positive way. http://research.asu.edu/ For the eleventh year in a row, ASU has been named the most innovative school in the nation, recognizing the university's culture of groundbreaking research and partnerships, as well as its commitment to helping students thrive in college and beyond. U.S. News and World Report have named ASU as the most innovative university all eleven years the category has existed. If interested, please apply here https://www.myworkday.com/asu/d/inst/15$158872/9925$21384.htmld Apply tot his job Apply To this Job