UNIV - Research Program Assistant: Journey - Pediatrics: PRG

Medical University of South Carolina•Charleston, SC

1d•Hybrid

About The Position

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.

Requirements

A high school diploma and two years 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.

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 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
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.
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).
Schedules and coordinates team meetings.
Assists with preparing meeting documents.
Maintains study compliance with institutional requirements and other policies and maintains the Delegation of Authority Logs.
Understands the ethical conduct of research and safeguards needed when conducting human subjects research activities.
Under supervision, adheres to management plans related to conflict of interest.
Administrative and other duties as assigned