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Job Offer: Director Human Subjects Protections:Rice UniversityJob description:Director Human Subjects ProtectionsBookmark this Posting Print Preview | Apply for this JobPlease see Special Instructions for more details.East Carolina University requires candidates to submit a candidate profile online in order to be considered for the position. Candidates must also submit a cover letter, resume, and a list of three references, including contact information, online.2-3 original letters of reference are required for employment. Please be aware that if selected as a candidate of choice, an automatic e-mail will be sent to the individuals entered by the applicant in the References section in the PeopleAdmin applicant tracking system. Letters of reference submitted via the PeopleAdmin applicant tracking system will be verified and considered towards meeting this requirement. candidates must be currently authorized to work in the United States on a full-time basis. Posting DetailsPosition InformationJob Title Director Human Subjects Protections Position Number 000442 Vacancy Open to All Candidates Department AAH REDE Institutional Review Board Department Homepage https://rede.ecu.edu/ora/ Advertising Department OFFICE OF RESEARCH INTEGRITY AND COMPLIANCE Division Academic Affairs Classification Title Director-Professional (Other) Working Title Director Human Subjects Protections Number of Vacancies 1 Full Time Equivalent (FTE) 1.0 Full Time or Part Time Full Time Anticipated Recruitment Range. income offered may be outside of this range as impacted by budget, UNC income administration, and/or candidate qualifications. $105,623 - $125,000 Position Location (City) Greenville Position Type Non-Faculty Job Category Non-Faculty Staff Professional Organizational Unit Overview Under delegated authority from the Chancellor of East Carolina University, the adjunct Vice Chancellor for Research Administration and Compliance in the Office of Research, is accountable to the Federal government and other regulatory agencies for protection of humans who are the subject of any research by investigators within East Carolina University. The University and Medical Center Institutional Review Board (UMCIRB) is the entity which supervises all human subject research, under delegated authority from the adjunct Vice Chancellor for Research Administration and Compliance. Such research includes clinical or patient-related research, such as clinical trials. Information technology also includes surveys and other types of research using human subjects, such as research conducted using children by the College of Education; psychological research involving adults and children; and all other types of human research all over the university. The UMCIRB's mission is critical to the university and local investigators because: (1) Information technology protects the rights and interests of human subjects; (2) protects the university and researchers by ensuring its function is in compliance with regulatory requirements; and (3) advises investigators in navigating the regulatory and compliance requirements that affect their work. Job tasks The Director of Human Subjects Protections is expected to function as a comprehensive IRB professional with an in-depth knowledge of the federal research regulations and the capability to direct and manage all aspects of the IRB process. The Director will ensure the overall effective operation of the regulatory, administrative, and business processes of the UMCIRB. The Director plays a vital function for ensuring that the UMCIRB office and committee operates in a manner consistent with the federal regulations through drafting, reviewing and revising IRB processes and procedures. This position is required to provide support to investigators, from novice to expert, in various disciplines across the university and hospital campuses in preparation of their IRB applications. This position performs the following tasks: Administration of Human Research Program - 60% » Provide human subject research guidance and education to UMCIRB staff and committee members, and faculty/staff/student investigators (individually or departmental) » Assist local investigators conducting human research in the development of their proposals to be submitted for IRB approval or External IRB confirmation » Assist local investigators and IRB members/chairs with non-human research activities such as Emergency Use and Expanded Access projects, and Humanitarian Use Devices. » Interact and communicate with local institutional and regulatory officials regarding human research » Recruit appropriate and engaged individuals to become UMCIRB members » Manage, train and support UMCIRB members on two boards (Biomedical and Behavioral/Social Sciences) » supervise HIPAA Privacy Board and HIPAA Research activities » Research, propose and develop necessary and appropriate policy/procedure changes within the UMCIRB according to local, state and federal policy changes and guidance » Compile, assess and manage UMCIRB data for institutional assessment purposes » Consult with and query federal regulatory agents (OHRP, FDA, DOD, etc.) as needed for guidance to ensure UMCIRB's satisfaction of regulatory requirements » Review and provide guidance to IRB Chairs/members on individual human research submissions » Prepare UMCIRB meeting agenda and minutes » Serve as the HHS, Office for Human Research Protections (OHRP) Human Protections Administrator (HPA) for ECU » Update and revise Federal Wide Assurance (FWA) and UMCIRB rosters with the Office of Human Research Protections (OHRP) » Draft and maintain ECU Individual Investigator Agreements with individual research team members » Draft, review and execute ECU IRB Authorization Agreements with collaborating institutions and external IRBs » Review Data Use Agreements to ensure alignment with research protocols » Investigate human research related serious or continuing non-compliance and unanticipated problems and report to appropriate local institutional officials, federal officials, sponsoring agencies and others as necessary » Supervise 5 full time employees to ensure compliance with significant regulatory/institutional policies and UMCIRB standard operating procedures Administration of electronic IRB submission system - 20% » Provide technical support to research investigators and others within the electronic IRB submission system » Manage and modify workflows/smartforms and troubleshoot issues within the electronic IRB submission system » Assist in report development from data collected within electronic IRB submission system for institutional purposes Education and Outreach - 20% » Develop education, training and resources for a variety of investigators and other customers as needed located on hot topics, new federal guidance or local policies/rules » Develop local tools for determining human subject research (versus case reports, quality activities, class projects, etc.) » Maintain and update UMCIRB website using university software Contingent upon availcapability of funds. Minimum Education/practice » Post-baccalaureate education in a significant scientific or health care discipline » Thorough knowledge of federal regulatory requirements regarding research involving humans, including regulations from FDA, DHHS, NIH, OCR. » Thorough knowledge of the research setting in a medical and health care environment. » Certification or certification-eligible as a Certified IRB Professional (CIP) » Strong communication expertise, both verbal and written » Working knowledge of federal requirements for research compliance » Familiar with Behavioral and/or Social Science research methods and procedures License or Certification Required by Statute or Regulation None Preferred practice, expertise, Training/Education » Graduate education with appropriate research practice » IRB administrative practice in health care environment » IRB committee practice including minute taking » Proficiency in superviseing and managing data in an electronic format/system » Familiarity with use of multiple electronic systems (i.e., external IRB systems, federal IRB systems, university electronic systems) Special Instructions to Applicant East Carolina University requires candidates to submit a candidate profile online in order to be considered for the position. Candidates must also submit a cover letter, resume, and a list of three references, including contact information, online. 2-3 original letters of reference are required for employment. Please be aware that if selected as a candidate of choice, an automatic e-mail will be sent to the individuals entered by the applicant in the References section in the PeopleAdmin applicant tracking system. Letters of reference submitted via the PeopleAdmin applicant tracking system will be verified and considered towards meeting this requirement. candidates must be currently authorized to work in the United States on a full-time basis. Additional Instructions to Applicant In order to be considered for this position, candidates must complete a candidate profile online via the PeopleAdmin system and submit any requested documents. Additionally, candidates that possess the preferred education and practice must also possess the minimum education/practice, if applicable. Job Open Date 09/30/2024 Open Until Filled No Job Close Date - Positions will be posted until 11:59 p.m. EST on this date. If no closing date is indicated, the position may close at any time after the initial screening date. 10/21/2024 Initial Screening Begins 10/14/2024 Rank Level Quick Link for Direct Access to Posting https://ecu.peopleadmin.com/postings/74837 AA/EOE East Carolina University is an equal opportunity and affirmative action employer who is committed to workforce success and cultivating a culture of care, belonging and opportunity for our faculty, staff and learners and all stakeholders. All qualified candidates will receive consideration for employment without regard to their race/ethnicity, color, genetic information, national origin, religion, sex, sexual orientation, gender identity, age, discapability, political affiliation, or veteran status. Individuals requesting accommodation under the Americans with Disabilities Act Amendments Act (ADAAA) should contact the ADA Coordinator at (252) 737-1018 (Voice/TTY) or E-Mail: ADA-Coordinator@ecu.edu. Eligibility for Employment Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. ECU participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States. Department for People Operations, Success, and Opportunity If you practice any problems accessing the system or have questions about the application process, Contact Us by the Department for People Operations, Success, and Opportunity at (252) 328-9847 or toll free at 1-866-489-1740 or send an email to employment@ecu.edu. Our office is available to provide assistance Monday-Friday from 8:00-5:00 EST. Supplemental QuestionsRequired fields are indicated with an asterisk (*).» * Will you now or in the future require visa sponsorship for employment? » Yes » No » * Please indicate where you learned about this job vacancy. » Chronicle of Higher Education » CareerBuilder » Greenville everyday Reflector » Raleigh News & Observer » InsightIntoDiversity.com » HigherEdJobs.com » InsideHigherEd.com » Monster.com » Indeed » ECU Website » Other Documents Needed To ApplyRequired Documents» Curriculum Vitae/Resume » Cover Letter » List of ReferencesOptional Documents Skills:
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