Clinical Research Coordinator - Neurology

Overview

Position Summary. This position will assist investigators as coordinator of basic to moderately complex clinical research studies examining the interaction of the gut microbiome, Alzheimer Disease, HIV and/or substance abuse on brain integrity. The CRC 1 may also assist in studies of dementia in adults with Down syndrome. The Coordinator may be responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community and the study participants;

responsible for recruitment, enrollment, data collection, maintenance of IRB approval, detailed study chart documentation and data entry, and managing and recording all phases of study protocol as required by sponsoring agency and PI to ensure compliance.

• Implements and manages all phases of study/protocol for up to 4 studies simultaneously; ensures compliance with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitors participants’ progress to include documentation and reporting of adverse events; maintains participant charts and regulatory binders; initiates IRB, RDRC, and IND applications, Data Use & Material Transfer Agreements, modifying as necessary; deals with protocol management issues and recommends corrective action as appropriate;
  
  serves as liaison with funding or sponsoring agency.
• Routinely makes and/or participates in making determinations of eligibility based on diagnostic criteria and/or observations/analysis in participant interviews; develops informed consent and intake packets for study participants and confers with participants to explain purpose of study and obtain completed informed consent packets; explains diagnostic procedures and treatment plans to address participant/family concerns; administers/scores tests and/or evaluates all lab and clinical assessments to ensure they are completed in a timely manner;
  
  responsible for careful review of medical records for inclusion/exclusion criteria, as well as clinical follow-up if necessary for participant safety/minimization of risk should an adverse event occur; ensures that all encounters are well-documented in the study chart; routinely collects clinical data (i.e., neuropsychological assessments, neuroimaging data, questionnaires, etc.) and biospecimens, such as blood, stool and urine samples, & CSF, and delivers to appropriate labs.
• Evaluates and interprets collected clinical data in conjunction with PI as appropriate; performs statistical analyses on data and takes the lead in writing progress reports. Assists in developing ideas for grant applications and provides written interpretation of current studies to be used as pilot data in these applications.
• Ensures timely completion of all protocol requirements (assessment, lab testing, procedures and treatments), to include scheduling and facilitating the patient’s timely completion of protocol requirements; evaluates and interprets collected clinical data as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same.
• Collects clinical data under clinical research protocols.
• Performs other duties as assigned.

Job Location /

Working Conditions:

Patient care setting.

Physical Effort: Typically sitting at desk or table.

Equipment: Office equipment.

Education: Required Qualifications — Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications / Professional Licenses: The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role. Basic Life Support - American Heart Association, Basic Life Support - American Red Cross

Work Experience: No specific work experience is required for this position.

Skills: Not Applicable

Driver s License: A driver s license is not required for this position.

More About This Job

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