UNIV - Research Program Coordinator II Journey - Pediatrics: PRG

Job Description Summary

This position is for a Part-time Program Coordinator II who, under the direction of the PI and Program Manager, assumes responsibility and accountability in management of study related procedures for patients enrolled in taVNS BabySTrong II research studies.


Is responsible for the clinical trial information required in maintaining Institutional Review Board (IRB) regulations and requirements for this FDA regulated clinical trial. Responsible for maintaining the site files for all studies. Responsible for overall study site management with regulatory, enrollment, scheduling, study procedures, treatment, budgeting as well as communication with the other trial site study coordinator.

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, Salary

Pay Grade

University-06

Pay Range

46,655.00 - 66,488.00 - 86,321.000

Scheduled Weekly Hours

20

Work Shift

Job Description

This position is for a Part-time Program Coordinator II who, under the direction of the PI and Program Manager, assumes responsibility and accountability in management of study related procedures for patients enrolled in taVNS BabySTrong II research studies. 

Is responsible for the clinical trial information required in maintaining Institutional Review Board (IRB) regulations and requirements for this FDA regulated clinical trial. Responsible for maintaining the site files for all studies. Responsible for overall study site management with regulatory, enrollment, scheduling, study procedures, treatment, budgeting as well as communication with the other trial site study coordinator.

In coordination with other research staff, will maintain and help perform a schedule for delivering taVNS paired with feeding twice daily for enrolled participants. Facilitates necessary procedures required for the study including but not limited to videofluoroscopic swallow studies; MRI/MRS; blood collection and plasma separation, alliquotting and storage in -80C freezer in SJCH; STEP developmental test; collecting parent-reported developmental questionnaires by phone or at clinic visit; collecting test-of-blinding questionnaires.  Position will also include coordination of pre- and post-treatment studies prior to discharge. 

Will enroll and consent participants along with PI and other coordinators. Guidance with the collection and entering all data from patient visits, answers query data in the EDC system for the clinical trials in a timely manner. Provides education to subjects in line with protocol requirements. Monitors and trains staff focusing on reporting adverse events as required per protocol, maintains screening, study visits, training and consent logs in Investigator site files.

Provides mentorship to junior staff members with areas of training and development regarding IRB submissions, staff training, conducting study visits, training in building relationships with monitors and sponsor/vendor personnel. 

Job Duties:

Research Operations Research Visits: 35% 

Synthesizes and interprets recruitment reports (Screened subject/screen failures/enrollment) to assess effectiveness of recruitment strategies and implements innovative solutions to maximize recruitment strategies by allocating resources appropriately. Provides oversight and training to entire team unit with regards to subject screening. Establishes systems and policies related to subject screening. Study visit preparation and documentation:  Provides oversight and training to study team members, including clinic staff, regarding preparation of study visits, maintenance of subject level documentation and maintenance and editing of study level SOPs. Conduct study visits: Serves as a team resource and trains others regarding the conduct of study visits, creation/maintenance/editing of study level SOPs and implementation of operational plans. May perform advanced clinical assessments or interventions and trains others on study assessments. Specimen collections:  Creates, optimizes, and oversees systems to collect, prepare, ship, and maintain inventory of research specimens and trains others on these tasks. Informed consent: Provides oversight (to include review) to study team members who conduct and document consent for participants in a variety of studies. Serves as an expert resource and trainer across department or unit on the consent process and related documentation. Investigational Prod