Clinical Research Coordinator I

About the Role

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 study participants. Responsible for managing and recording all phases of study protocol as required by the sponsoring agency to ensure compliance. This position entails working with patients in the Newborn Intensive Care Unit at St. Louis Children’s hospital for multiple studies. There will be some hands-on requirement for this position, depending upon the study or clinical trial.

Key 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 the purpose of the 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.

Working Conditions

• Patient care setting.
• Typically sitting at desk or table.
• Office equipment.

Requirements & Tech Stack

• Basic Life Support (BLS) certification - American Heart Association or American Red Cross. Online BLS certifications without a skills assessment component are not sufficient.

Qualifications

• Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
• Clinical Research
• Clinical Study Protocols
• Communication
• Computer Systems
• Interpersonal Communication
• Organizing
• Research Support

A driver's license is not required for this position.