MUSC Health · 2 days ago
UNIV - Program Coordinator I - Journeyman - Pediatrics: PRG
Charleston
Full-time
Hybrid
Entry, Mid Level
2+ years expThe Medical University of South Carolina is a leading institution in healthcare and research, and they are seeking a Program Coordinator I to provide technical and professional services within the Pediatric Research Group. The role involves assisting in the coordination of human subject activities, managing study implementation, and ensuring compliance with regulatory standards.
Health CareHospitalMedical
Responsibilities
Screens participants for all studies independently (i.e screening for eligibility criteria)
Maintains subject level documentation for all studies independently
Conducts and assist with study visits, performs research procedures and research assessments. Extracts data from EPIC
Performs transcutaneous vagus nerve stimulation per protocol: applies ear electrodes, determines perceptual threshold, initiates stimulation per randomized assignment, monitors vital signs, coordinates stimulation with suck swallow during feeding
Conducts and/or documents consent for participants in a variety of studies independently applying knowledge of human subject’s protection regulations in the informed consent process
Makes recommendations to investigators and oversight organizations regarding site equipment and recruitment, for a clinical trial
Determines and allocates resources at a study level
Develops study protocol-specific systems and documents including process flows, training protocols/ manuals, standard operating procedures, and case report forms
Ensures study teams are compliant with institutional requirements/policies: provides training to staff around these feeding protocols and policies and ensures appropriate study specific training plans per Delegation of Authority Logs. Responsible for maintaining protocol specific training of all staff members listed on Delegation of Authority logs
Create and maintain the study databases
Uses EDC systems to enter data, in a timely manner. Detects issues related to data capture, collection or management and suggests solutions. Responsible for response to study specific queries within the EDC system in a timely manner
Creates data collection forms (CRFs and/or source documents) according to protocol
Completes basic statistical analysis
Prepares for and participates in team meetings. Serves as a primary liaison between Sponsor, PI, program managers, vendors, sub-contracts, and ancillary services including Imaging and Hospital services, etc., in the coordination of services needed
Assists with management and tracking of Investigation Product (IP) during study visits at the protocol and subject level
Collects, prepares, processes, and maintains inventory of research supplies used and patient specific MR scans, and provides guidance on system improvements related to MR handling
Corrects audit/monitor findings
Work with PIs on reporting adverse events to the IRB
Reviews study participant charges, identifies discrepancies and escalates to appropriate offices to ensure appropriate research billing compliance
Order supplies as needed to continue the study
Completes IRB and/or Sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events
Other Duties as Assigned
Qualification
Required
A bachelor's degree
Two years of relevant program experience
Ability to perform job functions in an upright position
Ability to perform job functions in a seated position
Ability to perform job functions while walking/mobile
Ability to work indoors
Ability to work outdoors in all weather and temperature extremes
Ability to work in confined/cramped spaces
Ability to perform job functions from kneeling positions
Ability to squat and perform job functions
Ability to perform 'pinching' operations
Ability to fully use both hands/arms
Ability to perform repetitive motions with hands/wrists/elbows and shoulders
Ability to reach in all directions
Possess good finger dexterity
Ability to maintain tactile sensory functions
Ability to lift and carry 15 lbs., unassisted
Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted
Ability to push/pull objects, up to 15 lbs., unassisted
Ability to maintain 20/40 vision, corrected, in one eye or with both eyes
Ability to see and recognize objects close at hand
Ability to see and recognize objects at a distance
Ability to determine distance/relationship between objects; depth perception
Good peripheral vision capabilities
Ability to maintain hearing acuity, with correction
Ability to perform gross motor functions with frequent fine motor movements
Company
MUSC Health
MUSC Health provides health-care services through its patient- and family-centered care, education, research, and various partnerships. It is a sub-organization of Medical University of South Carolina.
Founded in 1824Charleston, South Carolina, USA
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$133MKey Investors
Armadale Capital
2019-12-19Debt Financing· $133M
Leadership Team
Erik Summers
Chief Medical Officer
Recent News
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