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Research Conflict of Interest

2 months ago


Baltimore, United States University of Maryland, Baltimore Full time

The Office of Accountability and Compliance/Conflict of Interest for the University of Maryland, Baltimore (UMB) has two (2) exciting opportunities for Research Conflict of Interest & Conduct Compliance Analysts. The Conflict of Interest Compliance Unit oversees the management of financial conflicts of interest in research at UMB. The Research Conflict of Interest & Conduct Compliance Analysts perform duties that support the mission and vision of the department. Benefits Information * The University of Maryland offers an attractive and comprehensive benefits package that prioritizes wellness, work/life balance, and professional development. This position participates in a retirement program that must be selected and is effective on your date of hire. Exempt regular staff receive a generous leave package that includes over 4 weeks of vacation accrued each year, paid holidays, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options. *Primary Duties * Monitor the compliance related policies and materials on UMBs internet and intranet sites to ensure consistent messaging. Identify and implement updates to information and documentation as required. * Maintain systems for handling of alleged violations of rules, regulations, policies, procedures, and standards of conduct. Plan and integrate process improvement enhancements into the reporting systems. * Explore alleged violations and make recommendations to initiate investigative procedures. Conduct investigations and make recommendations for resolution. Ensure relevant compliance issues are reported. * Assist in the design, implementation, and administration of research implementation processes which include the identification and assessment of areas of research compliance risk and vulnerability. Recommend and ensure implementations of policies and other appropriate corrective actions including reporting of compliance issues. Ensure adherence with all international, federal, state and local regulations, laws, policies and guidelines. * Assist in guidance of researchers and research staff on current research regulatory and ethical compliance, requirements, and standards, human subjects and animal protection issues. Assist in training and mock reviews to facilitate education and training. * Identify and assist in the development and implementation of communication strategies regarding relevant research compliance issues and external audit information. * Facilitate new research studies, to include the informed consent, for Departmental and Institutional Review Board (IRB) review in the IRB's electronic system. * Process continuing reviews and amendments for IRB-approved studies before submission deadlines. Communicate with the Institutional Review Board (IRB) to resolve administrative modifications and address queries. * Facilitate and complete new protocols for FDA and IND submissions. May assist principal investigators (PIs) in preparing the protocol and informed consent form for PI-initiated research studies. * Prepare and analyze periodic reports including findings, recommendations, and planned corrective action. Report statistical findings that include information obtained through calls/reports submitted to the compliance hotline. * Coordinate the disclosure and review process for routine conflict of interest (COI) cases, including helping UMB employees complete COI disclosure documents, and drafting COI exemption letters. * Design and produce internal publications to assist in the advance of the goals of the program including the development and roll-out of any necessary training. * Provide information to internal campus and external stakeholders in connection with research compliance regulations, laws, guidelines, policies, and processes at UMB. * Performs other duties as assigned. Education: Bachelors degree in a relevant field. Experience: Two (2) years of research experience preferably in an academic or healthcare research setting or in corporate, government, or regulatory agency compliance-oriented role. Previous legal or paralegal experience preferred. Knowledge, Skills, and Abilities * Ability to adapt quickly and prioritize tasks effectively. * Demonstrate strong organizational, communication (written and verbal), and interpersonal skills; Ability to draft error-free and high-quality written communications (e.g. reports, memoranda, correspondence) with minimal direction or supervision. * Ability to effectively carry out investigations of compliance violations. * Demonstrate strong computer skills and possess an ability to learn internal information management systems. * Ability to employ a high degree of discretion, tact, and diplomacy in dealing with senior level internal and external contacts. * Ability to work with highly confidential and sensitive information. / The Hiring Range for this position is in the $70,000s, commensurate with education and experience. / UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy. For assistance related to employment, please contact the Staffing department at HRJobs@umaryland.edu. If you anticipate needing a reasonable accommodation for a disability under the Americans With Disabilities Act (ADA), during any part of the employment process, please submit aUMB Job Applicant Accommodation Request. You may also contact HRDiversity@umaryland.edu. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address. Job: Reg or CII Exempt Staff* *Organization: Office of the VP for OAA/Dean *Title: *Research Conflict of Interest & Conduct Compliance Analyst Location: null Requisition ID: 2400010N