UNIV - Research Assistant - Journey - Pediatrics: PRG

Medical University of South Carolina•Charleston, SC

2d•$37,200 - $59,500•Hybrid

About The Position

The Research Assistant will support clinical research activities within the Pediatric Research Group (PRG). This role involves direct patient interaction and independent work on minimal risk studies. Research Assistants contribute to the day-to-day operations of clinical research, including data collection, compilation, and documentation. The position will also support other PRG coordinators with interventional/drug studies under direct supervision.

Requirements

A high school diploma and four years of relevant program experience.
A bachelor's degree may be substituted for the required program experience.

Responsibilities

Collect, process, ship, and maintain inventory of research biological specimens.
Schedule study visits and assessments per protocol.
Maintain accurate and up-to-date paper and electronic regulatory documents.
Complete data entry in a timely manner, including query resolution.
Help with study recruitment efforts by completing pre-screening phone calls, reviewing medical charts, and speaking with subjects directly about enrolling studies during clinic visits.
Prepare lab kits for upcoming study visits, monitor inventory of lab kits and study-specific supplies, and destroy expired lab kits as needed.
Provide support to other PRG coordinators during study visits, including calling subjects to confirm appointments, filling documents, obtaining signatures from research staff in other MUSC locations, assisting with medical history and adverse event collection and documentation, and reviewing outside medical records.
Assist with study-specific worksheet and source document creation.
Conduct visits for minimal risk studies independently.
Perform assessments for minimal risk studies or for greater than minimal risk studies under direct supervision.
Collect data directly from participants or from the electronic medical record.
Process and ship labs.
Conduct and/or document consent for participants in minimal risk studies.
Conduct consent for studies greater than minimal risk under direct supervision.
File regulatory documents and reports.
Create a broad array of regulatory submissions (initial study applications) for minimal risk studies.
Create and submit simple regulatory reports (personnel amendments and continuing review applications) to the IRB.
Prepare for study monitoring and study audit visits.
Address findings and resolve queries under supervision.
Collect, prepare, or process adverse events under supervision.
Administratively file external SAE reports or IRB SAE reports.
Complete case report forms and enter data into EDC system(s).
Resolve data queries.
Create and develop simple databases.
Assist with the creation of simple data collection forms (surveys, CRFs, and/or source documents).
Schedule and coordinate team meetings.
Assist with preparing meeting documents.
Understand the ethical conduct of research and safeguards needed when conducting human subjects research activities.
Adhere to management plans related to conflict of interest under supervision.
Maintain study compliance with institutional requirements and other policies.
Maintain the Delegation of Authority Logs.
Perform administrative and other duties as assigned.