Job Description Summary

Serve as a Program Coordinator I who provides technical and professional services within the Pediatric Research Group (PRG).

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC001014 COM PEDS Clinical Research CC

Pay Rate Type

Hourly

Pay Grade

University-05

Pay Range

39,764.00 - 56,670.00 - 73,576.000

Scheduled Weekly Hours

20

Work Shift

Job Description

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 after one year of employment.

May be required to work weekends.

Job Duties:

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 subject’s protection regulations in the informed consent process.

Site and Study Management: 15%

• 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.

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.

Communication: 15%

• 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.

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.

Research Operations -Regulatory 5%

• 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 5%

Additional Job Description

Minimum Requirements: A bachelor's degree and two years of relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 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.

Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees