Job Description

Position assists investigators as a data coordinator of clinical research trials of all complexities, extracting data from the Electronic Medical Record (EMR) and other source documents and entering it into an Electronic Data Capture (EDC). May be responsible for numerous research trials simultaneously. Helps ensure the accurate collection of study-required procedures while patients are receiving protocol treatment and are in active protocol follow-up; acts as liaison between the School, trial sponsors, vendors, and the study team. Responsible for helping the clinic coordinator and Principal Investigator (PI) manage and record data for all phases of study protocol as required by sponsoring agency to ensure compliance, patient safety and welfare, and data integrity. Primary Duties & Responsibilities: Assists in developing plans for research projects and discusses the interpretation of results; collaborates in the preparation of manuscripts for publications and preparation of grant proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate. Coordinates the development of forms, questionnaires and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies. Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency. 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. Performs other duties as assigned. Working Conditions: Patient care setting. Physical Effort: Typically sitting at desk or table. Equipment: Office equipment. Required Qualifications: Bachelor’s degree or combination of education and/or experience may substitute for minimum education. Certifications: 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: Required Qualifications: Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements). Preferred Qualifications: Education: No additional education beyond what is stated in the Required Qualifications section. Certifications: No additional certification beyond what is stated in the Required Qualifications section. Work Experience: No additional work experience beyond what is stated in the Required Qualifications section. Skills: Clinical Research, Clinical Study Protocols, Database Management, Research Projects, Spreadsheet Analysis, Statistical Analysis Software (SAS).

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