UNIV - Program Coordinator I Journey - Pediatrics Pediatrics Research Group

Job Description Summary

Job Purpose: Serve as a Program Coordinator I who provides technical and professional services within the Pediatric Research Group (PRG). The position will assist the Program Manager the Principal Investigators (PI) and other research assistants involved in the coordination of human subject activities as delegated by the Program Manager and PI.

Entity

Medical University of South Carolina (MUSC Univ)

Worker Type

Employee

Worker SubType

Research Grant

Cost Center

CC001013 COM PEDS Childrens Research Institute CC

Pay Rate Type

Hourly

Pay Grade

University05

Pay Range

38985...000

Scheduled Weekly Hours

20

Work Shift

Job Description

Job Purpose: Serve as a Program Coordinator I who provides technical and professional services within the Pediatric Research Group (PRG). The position will assist the Program Manager the Principal Investigators (PI) and other research assistants involved in the coordination of human subject activities as delegated by the Program Manager and PI. Responsibilities include site management and navigating study implementation of clinical trials recruitment of study participants scheduling study visits data collection conducting research protocols and assessments collecting MR scans from radiology for processing and maintaining up to date regulatory files.

This position will be required to come on campus for treatments but may be eligible to work a hybrid work from home model at other times. May be required to work weekends.

Preferred:

Experience with clinic trials or human subjects.

Experience with statistical Analysis

Experience with Microsoft Excel

Experience with feeding techniques for infants and scoring feeding skills

Experience with noninvasive brain stimulation treatments

Research Operations:

Research Operations Patient Visits 35

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 subjects protection regulations in the informed consent process.

Research Operations Regulatory 5

Completes IRB and/or Sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. nonreportable adverse events.

Site and Study Management: 20

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 protocolspecific 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 for maintaining protocol specific training of all staff members listed on Delegation of Authority logs.

Research Operations Administrative 10

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.

Communication: 10

Prepares for and participates in team meetings. Serves as a primary liaison between Sponsor PI program managers vendors subcontracts and ancillary services including Imaging and Hospital services etc. in the coordination of services needed.

Data and Informatics: 15

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.

Other Duties as Assigned 5

Additional Job Description

Minimum Requirements: A bachelors degree and two years of relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous 68 hours per shift; Frequent 26 hours per shift; Infrequent 02 hours per shift) 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. (Frequent) 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 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 perform gross motor functions with frequent fine motor movements. (Frequent)

If you like working with energetic enthusiastic individuals you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race color religion or belief age sex national origin gender identity sexual orientation disability protected veteran status family or parental status or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications merit and business need.

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