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Medical University of South Carolina

Health sciences university in Charleston, SC

Program Coordinator 1 - Pediatrics: PRG

Full-TimeUpdated on 10/23/2026
$53.1k - $90.4k
Junior
Bachelor's
Charleston, SC, USA
In Person
Biology & BiotechClinical Research Operations

About the job

Requirements
  • A bachelor's degree and two years of relevant program experience are required.
  • The role requires the ability to perform the listed physical functions, including working upright, seated, and while walking or mobile; working indoors and occasionally outdoors or in confined spaces; kneeling, squatting, pinching, reaching, and repetitive hand, wrist, elbow, and shoulder motions; using both hands and arms with good finger dexterity and tactile sensory function; lifting, lowering, and pushing or pulling objects up to 15 pounds; maintaining corrected 20/40 vision, near and distance vision, depth perception, peripheral vision, and corrected hearing; and performing gross motor functions with frequent fine motor movements.
Responsibilities
  • Coordinate with the Program Manager, Principal Investigators, and research personnel involved in human research as delegated.
  • Serve as the primary coordinator on studies and provide backup or additional support for other Pediatric Research Group coordinators, including direct patient contact.
  • Schedule and conduct study visits and assessments according to protocol.
  • Collect, process, ship, and maintain inventory of research biological specimens.
  • Ensure timely and accurate data collection following Good Clinical Practice and ALCOA++ guidelines.
  • Maintain accurate and up-to-date paper and electronic regulatory files.
  • Perform prescreening, medical chart review, and in-person discussions with study investigators to support recruitment.
  • Prepare essential study documents, including worksheets, source documents, and study logs.
  • Assist with and complete Institutional Review Board submissions, including initial submissions, amendments, reportable events, and continuing reviews.
  • Serve as the primary liaison between site staff, sponsors, study vendors, and internal departments involved in clinical research.
  • Develop recruitment strategies, plans, and tools; engage the community and physicians; and identify barriers to recruitment.
  • Independently screen participants for study eligibility and maintain subject-level documentation for all studies.
  • Train others on Good Clinical Practice guidelines related to study documentation.
  • Independently conduct study visits and perform complex research assessments; extract complex data from electronic medical records.
  • Train others to conduct study visits and perform protocol-specific testing and interviews.
  • Collect, prepare, process, and ship research specimens; maintain specimen inventory; and provide guidance on specimen-handling system improvements.
  • Conduct and/or document consent for participants in minimal-risk studies, and conduct consent for greater-than-minimal-risk studies under direct supervision.
  • Assist with management and tracking of investigational product at protocol and subject levels, employ required systems for its handling, dispensing, and documentation for sponsored protocols, and determine handling and documentation methods for investigator-initiated protocols as needed in coordination with investigational pharmacies.
  • Ensure studies comply with the Code of Federal Regulations, Good Clinical Practices, and MUSC policies; maintain study registration; create initial regulatory submissions and annual reports for greater-than-minimal-risk studies; act as a site liaison for external Institutional Review Board submissions and reporting; and independently correct audit and monitoring findings.
  • Collect, prepare, or process adverse events under supervision; independently complete Institutional Review Board and sponsor reportable events; and apply protocol and institutional guidelines to distinguish reportable from non-reportable adverse events.
  • Review study participant charges in the medical record and route them according to the Study Billing Plan.
  • Complete case report forms, enter data into electronic data capture systems, resolve data queries, and assist in creating simple data collection forms, surveys, case report forms, and source documents.
  • Prepare for and participate in team meetings; liaise with sponsors, Principal Investigators, vendors, subcontractors, and ancillary services, including Investigational Drug Services Pharmacy, laboratory, imaging, NEXUS, and hospital services.
  • Under direction, provide data for external monitoring reports and facilitate completion of documents related to Research Data Security Plans, Data Safety and Monitoring Plans, and conflicts of interest; safeguard ethical conduct of human-subjects research.
  • Collect recruitment and resource information to help study teams determine site trial feasibility; determine and allocate resources at the study level; develop protocol-specific systems and documents, including process flows, training manuals, standard operating procedures, and case report forms; and ensure study teams comply with institutional requirements and policies, including training staff and ensuring study-specific training plans are maintained in Delegation of Authority Logs.
  • Perform other duties as assigned.

About the company

M

Medical University of South Carolina

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Medical University of South Carolina is a public academic health sciences university in Charleston, South Carolina. It offers bachelor's, master's, doctoral, and professional degrees through six colleges in dental medicine, graduate studies, health professions, medicine, nursing, and pharmacy.

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