Clinical Research Coordinator I - Nephrology

About this role

Location SAINT LOUIS, MO 63110

 Scheduled Hours 40

Position Summary Assists investigators as coordinator of a basic to moderately complex clinical research study; may be 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 the sponsoring agency to ensure compliance.

This is a time-limited position

Job Description

Primary Duties & Responsibilities:

• 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 to 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. • Recruits and enrolls study participants; makes and/or participates in making determinations of eligibility based on diagnostic criteria and/or observations/analysis in participant interviews; develops informed consent 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. • 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.

The Transplant Nephrology Section is looking for a third full time research coordinator (level 1 or 2). The coordinator does not have to be an RN. International MD are welcome to apply. Here are some of the main tasks of the coordinator:

• Supports, facilitates and coordinates clinical trial activities and plays an important role in the conduct of a study • Coordinates with PI, institution, department and corresponding offices to ensure that study-related activities are in compliance with federal and university policies and procedures • Coordinates and facilitates monitoring and audit visits and notifies all appropriate personnel/offices. • Assists the PI in study feasibility, qualification, selection and initiation visits to ensure proper conduction of such study-related events. • Conducts and/or participates in discussing and consenting patients, and ensures that all questions and concerns related to study participation are answered appropriately. • Screens participants for eligibility and coordinates with study visits, ensuring that all visits are entered in the billing matrix and OnCore and study EDC. • Maintains inventory of supplies and ensures that all study kits/equipment are up-to-date, and that expired kits/supplies are properly disposed based on the university’s policies and guidelines. • Ensures complete study documentation and maintenance of files, and are in accordance with WashU, IRB, study sponsor policies and guidelines. • Coordinates and communicates between sponsor, IRB, and PI accordingly especially in matters pertaining to study participants and their safety. • Assists in study closeout and ensures that documents follow university and study requirements

Working Conditions: Job Location/Working Conditions • Patient care setting.

Physical Effort • Typically sitting at desk or table.

Equipment • Office equipment.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education: 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 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 unless stated elsewhere in the job posting. Certifications /Professional Licenses : No additional certification/professional licenses unless stated elsewhere in the job posting. Work Experience: No additional work experience unless stated elsewhere in the job posting.

Skills: Clinical Research, Clinical Study Protocols, Communication, Computer Systems, Interpersonal Communication, Organizing, Research Support

Grade C09

Salary Range $49,200.00 - $73,800.00 / Annually

The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors in

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