UNIV - Program Coordinator I - Journeyman - Pediatrics: PRG

Medical University of South Carolina•Charleston, SC

19h•Hybrid

About The Position

Serve as a Program Coordinator I who provides technical and professional services within the Pediatric Research Group (PRG). The position will assist the Program Manager, the Principal Investigators (PI), and other research assistants involved in the coordination of human subject activities as delegated by the Program Manager and PI. Responsibilities include site management and navigating study implementation of clinical trials, recruitment of study participants, scheduling study visits, data collection, conducting research protocols and assessments, collecting MR scans from radiology for processing, and maintaining up to date regulatory files. This position will be required to come on campus for treatments but may be eligible to work a hybrid work from home model after one year of employment. May be required to work weekends.

Requirements

A bachelor's degree and two years of relevant program experience.

Responsibilities

Research Operations- Patient Visits
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, performs research procedures and research assessments.
Extracts data from EPIC.
Performs transcutaneous vagus nerve stimulation per protocol: applies ear electrodes, determines perceptual threshold, initiates stimulation per randomized assignment, monitors vital signs, coordinates stimulation with suck swallow during feeding.
Conducts and/or documents consent for participants in a variety of studies independently applying knowledge of human subject’s protection regulations in the informed consent process.
Site and Study Management:
Makes recommendations to investigators and oversight organizations regarding site equipment and recruitment, for a clinical trial.
Determines and allocates resources at a study level.
Develops study protocol-specific systems and documents including process flows, training protocols/ manuals, standard operating procedures, and case report forms.
Ensures study teams are compliant with institutional requirements/policies: provides training to staff around these feeding protocols and policies and ensures appropriate study specific training plans per Delegation of Authority Logs.
Responsible for maintaining protocol specific training of all staff members listed on Delegation of Authority logs.
Data and Informatics:
Create and maintain the study databases.
Uses EDC systems to enter data, in a timely manner.
Detects issues related to data capture, collection or management and suggests solutions.
Responsible for response to study specific queries within the EDC system in a timely manner.
Creates data collection forms (CRFs and/or source documents) according to protocol.
Completes basic statistical analysis.
Communication:
Prepares for and participates in team meetings.
Serves as a primary liaison between Sponsor, PI, program managers, vendors, sub-contracts, and ancillary services including Imaging and Hospital services, etc., in the coordination of services needed.
Research Operations- Administrative
Assists with management and tracking of Investigation Product (IP) during study visits at the protocol and subject level.
Collects, prepares, processes, and maintains inventory of research supplies used and patient specific MR scans, and provides guidance on system improvements related to MR handling.
Corrects audit/monitor findings.
Work with PIs on reporting adverse events to the IRB.
Reviews study participant charges, identifies discrepancies and escalates to appropriate offices to ensure appropriate research billing compliance.
Order supplies as needed to continue the study.
Research Operations -Regulatory
Completes IRB and/or Sponsor reportable events independently.
Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.
Other Duties as Assigned