UNIV - Research Program Coordinator I Journey - Pediatrics: PRG

Job Description Summary

The Research Study 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

CC001014 COM PEDS Clinical Research 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 Research Study 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 Research Study 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.

Research Operations (35%): Develops recruitment strategies, plans, and tools. Engages the community, physicians, and identifies barriers to recruitment.  Screens participants for all studies independently (i.e screening for eligibility criteria).  Maintains subject level documentation for all studies independently. Train others on Good Clinical Practice guidelines related to study documentation. Independently conducts study visits and may perform complex research assessments. Extracts complex data from electronic medical records. May train others to conduct study visits and perform protocol specific testing/interviews.  Collects, prepares, processes, ships, and maintains inventory of research specimens and provides guidance on system improvements related to specimen handling. Conducts and/or documents consent for participants in minimal risk studies. May conduct consent for studies greater than minimal risk under direct supervision.  Assists with management and tracking of IP at the protocol and subject level. Employs the required system for handling, dispensing, and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling & documenting IP for investigator-initiated protocols and coordination with investigational pharmacies as necessary.  Ensures studies are carried out according to Code of Federal Regulations, Good Clinical Practices, and MUSC policies. Maintains accurate study registration (Clinicaltrials.gov, etc.). Independently creates initial regulatory submissions and annual reports to Federal regulatory authorities and funding agencies (NIH, FDA, etc.) for greater than minimal risk studies. Acts as a site liaison for external IRB submissions and reporting. Corrects audit/monitor findings independently.  Collects, prepares or processes adverse events under supervision.  Completes IRB and/or Sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.  Reviews study participant charges in the