Clinical Research Coordinator I - Pediatric Endocrinology

Location

SAINT LOUIS, MO 63110

 Scheduled Hours

40

Position Summary

We are seeking a motivated, detail-orientated Clinical Research Coordinator to assist investigators as coordinator of basic to moderately complex clinical research studies; 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.

As part of the study team, you will interact with both pediatric participants and their families. Key responsibilities include participant screening and enrollment, scheduling and conducting study visits, collecting tracking and managing initial antibody screening tests and results, data entry, regulatory and study management, and other various coordinating activities.

Job Description

Primary Duties & Responsibilities:

Implements and manages all phases of clinical research studies, protocols, and related program activities; ensures compliance with protocol guidelines and requirements of regulatory agencies and sponsoring organizations; establishes and maintains appropriate record-keeping systems; monitors participants’ progress and study activities; 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 investigators, clinical teams, funding or sponsoring agency, and study participants and families.

Recruits and enrolls study participants and/or facilities participation in research and screening activities; makes and/or participates in making determinations of eligibility based on established study criteria and participant information; develops and/or maintains study materials and informed consent documentation, as applicable; communicates with study participants and families regarding study purpose, procedures, screening opportunities, and visit requirements; address routine participant and family questions and facilitates

communication with appropriate clinical or research personnel.

Ensures timely completion of all protocol and program requirements, including assessment, laboratory testing, procedures, visits, and follow-up activities; coordinates study and/or screening activities, results, and follow-up requirements, as applicable; evaluates and interprets collected clinical data as appropriate; prepares oral or written presentations or reports summarizing study or program activities and progress.

Collects, enters, maintains, and manages clinical and research data in accordance with approved protocols and established data-management procedures, including maintaining study-specific databases and tracking participant, laboratory, screening, and follow-up information, as applicable.

Performs other duties as assigned.

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