UNIV - Program Assistant - Journeyman - Department of SCTR
About The Position
This position provides administrative and technical support for programs within the South Carolina Clinical and Translational Research Institute (SCTR). It serves as a Junior Research Coordinator within the Research Coordinator and Management Core (RCM) fee-for-service component, assisting MUSC investigators. Responsibilities include recruitment of study participants, data entry and filing, and scheduling study visits. This role is part of SCTR's Research Nexus Research Coordination and Management mentorship program and is designed as an entry-level position to foster career development for professional Research Coordinators. The candidate must be willing to work rotating shifts with flexible hours, overtime if required, and may involve overnight and local area travel.
Requirements
- A high school diploma and three years of relevant program experience.
- A bachelor's degree may be substituted for the required program experience.
Responsibilities
- Provides administrative support for recruitment strategies, including preparing mailings, distributing flyers, and phone marketing.
- Offers administrative pre-screening support to the study team, potentially maintaining logs and data entry related to screening.
- Schedules participants for study visits.
- Assists with the preparation and gathering of study supplies, equipment, and documents as needed.
- Prepares for study monitoring and study audit visits, and may assist with addressing findings and resolving queries under supervision.
- Collects, prepares, or processes adverse events under supervision.
- Reviews study participant charges in the medical record and ensures proper routing according to the Study Billing Plan.
- Conducts visits for minimal risk studies independently and may perform assessments for minimal risk studies or greater than minimal risk studies under direct supervision.
- Collects data directly from participants 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, and 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.
- Administratively files external SAE reports or IRB SAE reports.
- Completes case report forms and enters data into EDC system(s).
- Resolves data queries.
- 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.
- Maintains the Delegation of Authority Logs.
- Administratively supports the RCM program.
- Performs other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
