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 three years of relevant program experience. A bachelor's degree may be substituted for the required program experience.
Ability to perform job functions in an upright position. (Frequent)
Ability to perform job functions in a seated position. (Frequent)
Ability to perform job functions while walking/mobile. (Frequent)
Ability to work indoors. (Continuous)
Ability to work outdoors in all weather and temperature extremes. (Infrequent)
Ability to work in confined/cramped spaces. (Infrequent)
Ability to perform job functions from kneeling positions. (Infrequent)
Ability to squat and perform job functions. (Infrequent)
Ability to perform 'pinching' operations. (Infrequent)
Ability to fully use both hands/arms. (Continuous)
Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent)
Ability to reach in all directions. (Frequent)
Possess good finger dexterity. (Continuous)
Ability to maintain tactile sensory functions. (Continuous)
Ability to lift and carry 15 lbs., unassisted. (Infrequent)
Ability to lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted. (Infrequent)
Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent)
Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent)
Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous)
Ability to see and recognize objects close at hand. (Frequent)
Ability to see and recognize objects at a distance. (Frequent)
Ability to determine distance/relationship between objects; depth perception. (Frequent)
Good peripheral vision capabilities. (Continuous)
Ability to maintain hearing acuity, with correction. (Continuous)
Ability to hear and/or understand whispered conversations at a distance of 3 feet. (Frequent)
Ability to perform gross motor functions with frequent fine motor movements. (Frequent)
Ability to work in dusty areas. (Infrequent)

Responsibilities

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