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Offer: Senior Research Integrity Administrator (Conflict of Interest and IRB Agreements):University of North CarolinaJob description:Senior Research Integrity Administrator (Conflict of Interest and IRB Agreements)Bookmark this Posting Print Preview | Apply for this JobPlease see Special Instructions for more details.» UNC Charlotte Benefits Information: https://hr.charlotte.edu/benefits/benefits-overview/» The finalist will be subject to a Criminal Background Check and/or a Motor Vehicle Report. Position InformationGeneral InformationPosition Number 003965 Vacancy Open to All Candidates Working Title Senior Research Integrity Administrator (Conflict of Interest and IRB Agreements) Position Designation EHRA Non-Faculty Employment Type Permanent - Full-time Months per Year 12 Work Schedule Monday - Friday, 8:00 am - 5:00 pm Hours per week 40+ Exempt FLSA Status Exempt Division Research Department Div of Research (Adm) Work Location Cameron Hall income Range $59,962 - $90,000 Primary Purpose of Department The Office of Research Protections and Integrity (ORPI) is part of the Division of Research. Information technology provides oversight, education, and support for integrity and compliance issues related to research and certain University operations at UNC Charlotte. The office ensures compliance with federal, state, and local applicable policies and laws on human subjects research, animal subjects research, biosafety, conflict of interest and commitment, research misconduct, responsible conduct or research, export control, and research security. Primary Purpose of Position The Senior Research Integrity Administrator provides program support to the Office of Research Protections and Integrity (ORPI) by performing various administrative, technical, and analytical tasks and day-to-day management of research compliance programs at UNC Charlotte. This position reports to and works closely with the Senior Executive Director of Research Protections and Integrity, Associate Director, IRB Manager, and IRB staff, assisting with the Conflict of Interest Program and Human Subjects Research Protection Program-related agreements. » Conflict of Interest - 80% » Human Subjects-related agreements - 20% Summary of Position Responsibilities The Senior Research Integrity Administrator coordinates and assists with administrative support for various compliance programs and/or processes assigned to the Office of Research Protections and Integrity. This includes Conflict of Interest and Commitment and Human Subjects Research Protection programs. Job Summary » Administer overlapping, multi-faceted research compliance programs according to institutional, governmental, or sponsor guidelines, policies, regulations, and laws. » Coordinate operational functions and build relationships with individuals/areas across the university impacted by research compliance regulations (i.e., One IT, Office of Research Services, Office of Research Commercialization and Partnerships, Human Resources, Facilities, International Students and Scholars Office, Travel, Finance, Office of Legal Affairs, Office of the Provost, and academic units). » Assist with developing, reviewing, and maintaining policies, procedures, tools, and resources in a changing regulatory environment. » capability to read and understand regulatory materials, apply regulatory knowledge to operational situations and communicate requirements to others. » Provide expert advice and guidance in a professional manner, both verbally and in writing to faculty, staff, and certain externally affiliated persons on regulations and sponsor requirements related to research compliance or University policy. » capability to assess unique and complex situations and recommend the most appropriate action. » capability to recognize urgent or critical matters and respond or escalate as required. » Identify program-related opportunities and gaps and recommend changes to ORPI leadership abilities. » Compile, organize, and secure information and prepare reports, records, and communications of a confidential nature to document regulatory compliance. » Maintain paper records, when applicable, and electronic databases of all responsible programs. » Assist with developing, implementing, and delivering education and training programs to ensure compliance with federal regulations, state laws, and institutional policies. » Develop and implement strategies for outreach (e.g., flyers, videos, website resources, virtual and in-person presentations, etc.). » Coordinate investigations and resolve complex problems, including but not limited to noncompliance issues. Specific tasks (Conflict of Interest and IRB agreements) » Monitor and communicate, both verbally and in writing, current and changing laws, regulations, policies, and procedures related to conflict of interest and commitment, including external professional activities, and identify and implement changes necessary to ensure compliance. » Organization of conflict of interest and commitment files. » Maintain intermediate knowledge of program-related technology, including but not limited to, the electronic Research Administration (eRA) system and various spreadsheet and document applications. » Assist with review of Conflict of Interest (COI) disclosures. Utilize the eRA system to document COI disclosure reviews, determinations, and communications. » Review award proposals and other proposal-related materials to ensure compliance with sponsor guidelines, including training requirements. » Review operational reports to facilitate COI program operations. » Perform simple user profile updates in the eRA for disclosure requirements and annual disclosure population management. » Receive and respond to user questions related to COI disclosure and External Professional Activities (EPA) submission in the eRA system. Troubleshoot user problems and actively listen to complaints and concerns. » Assist with developing and implementing COI management plans. » Assists in investigations of security incidents and remediation of inaccurate or incomplete form submissions within the UNC Charlotte research enterprise that include, but are not limited to, failure to properly disclose conflicts of interest or commitment, external professional activities, or participation in Malign Foreign Government Talent Recruitment Programs. » contact with governmental and non-governmental organizations to ensure compliance with contracts and agreements related to research, travel disclosure, and visiting researchers. » Partner and work directly with faculty, staff, and other University offices, including the Offices of Legal Affairs, OneIT, and Office of Research Commercialization and Partnerships (ORCP), to review and propose language and terms to mitigate potential risks to the University and support human subjects-related agreements to investigators. » supervise the facilitation of establishing and managing reliance agreements with external institutions or entities, including negotiation, documentation, and continuing communication, to ensure compliance with regulatory requirements. » Data security: stay abreast of data security best practices, including the use of apps in research, cloud-located data storage, storage of sensitive and identifying information, and secure data enclaves. » Collaborate with external IRBs, coordinating and reviewing collaborative interinstitutional reliance agreements; coordinate with IRB staff, faculty, and students; and track submissions to external IRBs. » Conduct comprehensive analyses of agreement provisions regarding human subjects research compliance and deliverables. » Ensure that the terms of all executed human subjects-related agreements appropriately follow regulations, policies, and institutional requirements for protecting and handling data originating from an IRB study. » Analyze complex requirements connected with both incoming and outgoing human subject research-related agreements. Including but not limited to IRB Authorization Agreements (IAAs) - IRB Reliance Agreements, Individual Investigator Agreements (IIAs), and Memorandums of knowledge (MOUs) Other Responsibilities » Supervise, assist, and mentor temporary staff or graduate adjuncts as needed. » Performs other tasks as assigned, including providing backup for the Conflict of Interest agent. Minimum Education/practice » Master's degree or » Bachelor's degree with 2-4 years practice, or an » Equivalent combination of education/practice. » practice can be paid or unpaid. Preferred Education, Knowledge, expertise and practice » Juris Doctorate and 1-2 years practice » Work both independently and under supervision. » Independently coordinate, manage, and complete assigned projects in a timely manner. Solution-oriented and takes responsibility for clarifying work requirements. » Handle multiple tasks thoroughly and efficiently. » Strong computer and software expertise, including knowledge of MS Office Suite and Google Suite. practice with Smartsheet valuable and desired. » Prior practice using infoEd Global software. » Have excellent oral and written communication expertise. » Have strong interpersonal, communication, organization, teamwork, and customer service expertise. » Prior administrative adjunct, compliance, or regulatory practice is a plus. » availability to learn, including acquiring new technical and professional expertise. Capacity to understand basic STEM-related topics. » capability to maintain confidential information at all times. » practice working in a high-volume, high-production, and/or sponsored-research-intensive environment. » practice with interinstitutional agreements, data use agreements, material transfer agreements, non-disclosure and confidentiality agreements, service agreements, and research agreements. » Familiarity with granting agencies (government, international, private, industry, etc.). » Knowledge of HIPAA and GDPR regulations is a plus. Necessary Certifications/Licenses Preferred Certifications/Licenses Special Notes to candidates » UNC Charlotte Benefits Information: https://hr.charlotte.edu/benefits/benefits-overview/ » The finalist will be subject to a Criminal Background Check and/or a Motor Vehicle Report. Posting Open Date 07/26/2024 Posting Close Date 08/18/2024 Open Until Filled No Proposed Hire Date 09/02/2024 If time-limited please indicate appointment end date Contact Information Posting Specific QuestionsRequired fields are indicated with an asterisk (*).» * How did you hear about this employment opportunity? » UNC Charlotte Website » HERC Job Board » Inside Higher Education » Circa (formerly known as Local JobNetwork) » Another Website » Agency Referral » Advertisement/Publication » Personal Referral » Other » Where did you lgain about this posting? (Open Ended Question) » * Please describe your practice with research compliance and/or Conflict of Interest (COI) research security. (Open Ended Question) » * Do you have any knowledge of any laws, policies, or regulations? Please explain. (Open Ended Question) » * What is your level of computer practice? Beginner, Intermediate, Advanced? (Open Ended Question) Applicant DocumentsRequired Documents» Resume / Curriculum Vitae » Cover Letter / Letter of Interest » Contact Information for ReferencesOptional Documents Skills:
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