Scheduled Hours

40

Position Summary

Position assists investigators as coordinator of moderately complex clinical research studies by managing enrollments, data, and research compliance needs related to Pediatric Hematology/Oncology. Position is responsible for multiple research studies simultaneously, acting as a liaison with the investigators, treating teams, pharmacy, laboratories, IRB, sponsors, and sponsor agencies. Position is responsible for managing and recording all phases of study protocol as required by sponsoring agency to ensure compliance.

Job Description

Primary Duties & Responsibilities:

• Routinely implements and manages all phases of study/protocol.
• Enrolls study participants.
• Participates in making determination of eligibility based on diagnostic criteria.
• Prepares informed consent packets for study participants.
• Ensures compliance with protocol guidelines and requirements of regulatory agencies In collaboration with the treating investigator, makes assessments and determinations of participants’ progress in the study.
• Extracts data accurately from source documents and reports in various data entry systems within the protocol deadlines.
• Notifies appropriate personnel regarding the ordering and administration of investigational agents.
• Investigates, analyzes, and reports adverse events.
• Makes decisions as when to notify physicians of issues, stop participant inclusion, and monitors for protocol compliance.
• Assists in the resolution of IRB and protocol management issues and recommends corrective action as appropriate.
• Serves as a liaison between institutional investigators, Human Research Protection Office, Operations Office, Siteman Cancer Center, Pharmaceutical Companies, Sponsoring Agencies, Center for Clinical Trials, and Patient Oriented Research Unit in Pediatrics.
• Works with audit teams during institutional site visits.
• Ships research samples when needed.
• Performs weekend/holiday call approximately once every 2-3 months for serious adverse event reporting for study participants; attends clinic and inpatient rounds to assist in study patient related concerns.
• Facilitates communication with investigators to ensure that study objectives are met in a timely manner; assists Senior Clinical Research Coordinators in alerting investigators and appropriate personnel of communications regarding adverse drug reaction reports and changes to protocols.
• Assists clinical staff with consenting participants for non-therapeutic clinical trials; assists clinical staff in administering patient reported outcome surveys and other participant questionnaires.
• 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