UNIV - Research Program Assistant: Journey - Pediatrics: PRG

Job Description Summary

The Research Assistant will support clinical research activities within the Pediatric Research Group. This role will have direct patient interaction and work on minimal risk studies independently. Research Assistants help with and participate in the day-to-day operations related to the collection, compilation, and documentation of clinical research data. This role will support other PRG coordinators with interventional/drug studies under direct supervision.

Medical University of South Carolina (MUSC – Univ)

Employee

Research Grant

CC001014 COM PEDS Clinical Research CC

Hourly

University‑04

$33,339.00 – $47,509.00 – $61,680.00

40

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

• 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 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 the inventory of lab kits and study specific supplies and destroy expired lab kits as needed.
• Provide support to other PRG coordinators during study visits as needed. This includes 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.

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%): Provides administrative support of recruitment strategies: prepares mailings, distributes flyers, phone marketing, etc. Provides administrative pre‑screening support to study team, may maintain logs and data entry related to screening. Schedules participants for study visits. May also assist with the preparation and gathering of study supplies, equipment, and documents as needed. Conducts visits for minimal risk studies independently. May also perform assessments for minimal risk studies or for greater than minimal risk studies under direct supervision.

Collects data directly from participant or from the electronic medical record. Collects, prepares, ships, and/or maintains inventory of biological research specimens and processes and ships labs. Conducts and/or documents consent for participants in minimal risk studies. May conduct consent for studies greater than minimal risk under direct supervision. Files regulatory documents and reports. Creates a broad array of regulatory submissions (initial study applications) for minimal risk studies.

Creates and submits simple regulatory reports (personnel amendments and continuing review applications) to the IRB. Prepares for study monitoring and study audit visits. May assist with addressing findings and resolving queries under supervision. Collects, prepares or processes adverse events under supervision. Administratively files external SAE reports or IRB SAE reports.

Data and Informatics (30%): Completes case report forms and enters data into EDC system(s). Resolves data queries. Creates and develops simple databases. Assists with the creation of simple data collection forms (surveys, CRFs, and/or source documents).

Communication (15%): Schedules and coordinates team meetings. Assists with preparing meeting documents.

Site and Study Management (10%): Maintains study compliance with institutional…