Lead Clinical Research Coordinator serves as primary resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the non-cancer Center for Clinical Research Management (CCRM) for the Department of Neurology, Division of Cognitive Neurology with a focus on memory disorders and neurodegenerative disease clinical trials; plans, implements & oversees daily conduct of protocol activities; serves as primary reviewer of patient records to assess & identify patients who meet criteria for participation in research studies in populations with cognitive impairment, mild cognitive impairment (MCI), Alzheimer’s disease, and related dementias, Huntington’s Disease (HD); recruits, interviews & promotes study to eligible patients; educates patients and families and/or caregivers of purpose, goals, & processes of clinical study; leads patient enrollment activities & ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements, including consent and assent processes appropriate for cognitively impaired participants; conducts standardized and protocol-specific cognitive testing for evaluation of participant eligibility and longitudinal assessment of cognitive outcomes across study visits; facilitates collection, processing & evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing commonly used in memory disorders trials (e.g., neuroimaging, biomarker collection); monitors patients for adverse reactions to study treatment or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care; documents unfavorable responses and notifies research sponsors & applicable regulatory agencies; participates in collecting, extracting, coding, & analyzing clinical research data, with particular emphasis on cognitive, functional, and behavioral outcome measures; monitors & ensures compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state & industry sponsor regulations; participates in planning and preparing for external compliance, quality assurance & control reviews; participates in development of new research protocols and contributes to planning of goals to meet study requirements for memory disorders and aging-related research; works closely with principal investigators upon awarding of new protocols and recommends team assignments; assists with preparation and submission of publications, research reports, and grant proposals; trains, mentors, and supervises clinical research staff, providing leadership in cognitive assessment administration, protocol adherence, data quality, and regulatory compliance.
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Job Type
Full-time
Career Level
Mid Level