UNIV - Research Program Coordinator I - Journey - Pediatrics: PRG

Job Description Summary

The Program Coordinator will be responsible for providing technical and professional support within the Pediatric Research Group (PRG) on interventional and observational clinical trials. The position will coordinate with the Program Manager, Principal Investigator(s) (PI), and other research personnel involved in human research as delegated. The Research study coordinator will be responsible for serving as the primary coordinator on studies as well as providing back-up or additional support for other PRG coordinators and will involve direct patient contact.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC001013 COM PEDS Children's Research Institute CC

Pay Rate Type

Hourly

Pay Grade

University-05

Pay Range

38,985.00 - 55,559.50 - 72,134.000

Scheduled Weekly Hours

40

Work Shift

Job Description

The Program Coordinator will be responsible for providing technical and professional support within the Pediatric Research Group (PRG) on interventional and observational clinical trials. The position will coordinate with the Program Manager, Principal Investigator(s) (PI), and other research personnel involved in human research as delegated. The Research study coordinator will be responsible for serving as the primary coordinator on studies as well as providing back-up or additional support for other PRG coordinators and will involve direct patient contact.

The Program Coordinator duties include:

• Scheduling and conducting study visits and assessments per protocol
• Collecting, processing, shipping, and maintaining inventory of research biological specimens
• Ensuring timely and accurate data collection following GCP and ALCOA++ guidelines
• Maintaining accurate and up-to-date paper and electronic regulatory files
• Performing pre-screening activities through screening, medical chart review, and in person discussions with study investigators to aide with recruitment
• Preparing and creating essential study documents including worksheets, source documents, and study logs
• Assisting with and completing IRB submissions, including initial submissions, amendments, reportable events, and continuing reviews
• Serving as the primary liaison between site staff, sponsors, study vendors and other internal departments involved in the conduct of clinical research

This position will be required to work on campus but may be eligible to work a hybrid work from home model after a probationary period. Position may also require weekend or after-hours work.

35% - Screens participants for all studies independently (i.e screening for eligibility criteria). Maintains subject level documentation
for all studies independently. Conducts and assist with study visits and may perform research assessments. Extracts data from EPIC.

20% - Independently creates regulatory submissions and annual reports to regulatory authorities …