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IRB Research Monitor
Required Qualifications (as evidenced by an attached resume):
Bachelor's degree (foreign equivalent or higher). In lieu of a Bachelor's degree, a combination of relevant higher education and experience totaling four (4) years may be considered. Three (3) years of full-time research regulation, monitoring, or coordinating experience. Experience with Microsoft Office and/or Google applications.
Experience in a human subjects' protection program. Experience with AAHRPP standards and accreditation requirements. Experience with the Health Insurance Portability and Accountability Act (HIPAA) regulations and state laws governing privacy. Experience managing electronic systems related to workflow and departmental operations which may include myResearch IRB. Experience with research procedures and terminology, medical terminology, clinical trials, and/or research data management. Experience with good clinical/research practices and standards.
Brief Description of Duties:
The clinical research monitor provides on-site oversight of clinical research with human subjects through monitoring activities intended to facilitate and ensure that research studies comply with the policies of the approved study protocol, the Institutional Review Board, Stony Brook University, government agencies (i.e. FDA, OHRP), and accreditation standards. The research monitor is independent of the study team conducting the research, and will report to the Office of Research Compliance. Activities include but are not limited to the following: ON-SITE pre-study resource evaluations, monitoring of ongoing trials, close-out monitoring of completed trials, and ongoing education.
The successful incumbent will have demonstrated leadership ability; excellent organizational and analytical skills; ability to apply sound judgment and take initiative in collection of information from a wide variety of sources; ability to identify and resolve issues; strong verbal and written communication skills; and exceptional professionalism and proven effectiveness as networker, communicator, problem-solver, and negotiator, with strong customer service orientation.
The research monitor conducts specific activities for clinical trials. In performing these activities, the research monitor conducts monitoring activities in accordance with established written procedures; utilizes appropriate monitoring checklists, report templates and source documents to record and report monitoring findings. The research monitor documents monitoring activities in writing, using specific report formats and communicates such findings to the appropriate parties (the principal investigator and designated members of the regulatory and clinical research staff).
Ensure protocol compliance (i.e. subject recruitment, eligibility criteria and informed consent procedures).
Ensure that only designated investigator(s) and/or appropriate clinical research staff are performing clinical trial functions.
Ensure that regulatory compliance is being maintained (i.e. that investigators are providing and maintaining all study related documents as required).
Communicate any serious deficiencies noted during monitoring to the appropriate parties and assists the study members in preparing the submission for myResearch IRB.
Work cooperatively with clinical research staff and investigators to address their concerns and to communicate findings that can lead to improved clinical research performance and/or compliance.
Review study related processes relative to applicable regulatory requirements, including the Food and Drug Administration Good Clinical Practice regulations and any departmental guidelines.
Review drug or device accountability, tracking records, and clinical research pharmacy processes. Verifies that appropriate drug/device storage, supply, usage, instruction, documentation and disposition are in place and followed.
Other duties as assigned.
The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.
Due to U.S. Export Control laws and regulations, the candidate hired will need to be a U.S. citizen, lawful permanent resident, or other "protected individual" (as defined by 8 U.S.C. Sec. 1324b(a)(3).
Resume/CV and cover letter should be included with the online application.
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at or visit OEA.
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SUNY Research Foundation: A Great Place to Work.
The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting.
To apply, visit https://stonybrooku.taleo.net/careersection/2/jobdetail.ftl?job=2303723&tz=GMT%2B00%3A00&tzname=UTC
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