"Clinical Research Coordinator II - Pediatrics"

Position Summary

The Center for Pediatric Pulmonary Disease & Allergy (PPD&A) is seeking an experienced research study coordinator that is interested in collaborating with multiple WASHU individuals/departments to help build a research program ‘from the ground up’. This newly developed Center is part of a vision of The Children’s Discovery Institute (CDI) to discover new precision therapies designed for individual patients. The PPD&A will focus on Cystic Fibrosis, Asthma and other Pediatric Pulmonary and Allergic Diseases.

This new coordinator will work with the project manager and Principal Investigators to develop and conduct PI initiated research protocols. The coordinator may be responsible for multiple research studies simultaneously, acting as a liaison with sponsoring agencies, the Institutional Review Board and study participants. The coordinator will be responsible for study start-up and execution, managing and recording all phases of study protocol, gain and maintain required regulatory approvals ensuring compliance and assist in building/maintaining databases for data repository.

Research studies will include pediatrics and/or adult participants

Job Description

Primary Duties & Responsibilities:

• Confers with PIs 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; 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

• Normal office environment
• Patient care setting
• Research laboratory

Physical effort

• Typically sitting at desk or table
• Typically standing or walking
• Occasional lifting (25 lbs or less)

Equipment

• Office equipment
• Lab/research equipment
• Other: Research Protocol specific

Required Qualifications

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

Certifications/Professional Licenses: Basic Life Support - American Heart Association, Basic Life Support - American Red Cross

Work Experience: Clinical Research (2 Years)

Required Qualifications

• Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Basic Life Support certification must be obtained within one month of hire date.

Preferred Qualifications

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

Grade

C10

Salary Range

$52,600.00 - $78,900.00 / Annually