"Clinical Research Coordinator II - Pediatric Clinical Research Unit"

Position Summary

Position assists investigators as coordinator of complex clinical research studies; responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community and the study participants; responsible for managing and recording all phases of study protocol as required by sponsoring agency to ensure compliance.

Job Description

Primary Duties & Responsibilities:

• Confers with PI to assist in developing plans for research projects and discuss 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.
• Routinely implements and manages all phases of study/protocol including recruitment, enrollment and eligibility as well as informed consent; 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 IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
• Evaluates and interprets collected clinical data in conjunction with PI 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 incidental to the work described herein.

Working Conditions:

Job Location/Working Conditions: Patient care setting, Exposure to blood-borne pathogens. Physical Effort: Typically sitting at desk or table, Typically standing or walking, Repetitive wrist, hand, or finger movement, Occasional lifting (25lbs or less). Equipment: Office equipment, Clinical/diagnostic equipment.

Required Qualifications

Education: 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: Clinical Research (2 Years).

Preferred Qualifications

Skills: Clinical Research, Clinical Study Protocols, Database Management, Research Projects, Spreadsheet Analysis, Statistical Analysis Software (SAS).

Salary Range

$52,600.00 - $78,900.00 / Annually