UNIV - Research Program Coordinator I - Journey - Department of PHS

Job Description Summary

Under the direct supervision of the Vice Chair for Research, Program Director and Program Coordinator II (PCII), the Program Coordinator I (PCI) will assist research investigators in the initiation, coordination, and management of clinical research trials and thus has a significant contribution to ensure assurance of sustainability, efficiency, and compliance. Assists with facilitating and coordinating the daily clinical trial activities and plays an active role in conducting the research studies. Exercises judgment regarding proper patient management, and provides support for the research investigators, faculty, fellows, PCII, and grants administrators.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC004533 COM RAD Administration CC

Pay Rate Type

Hourly

Pay Grade

University-GEN08

Pay Range

45,300.00 - 61,100.00 - 77,000.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Job Description:

Under the direct supervision of the Vice Chair for Research, Program Director and Program Coordinator II (PCII), the Program Coordinator I (PCI) will assist research investigators in the initiation, coordination, and management of clinical research trials and thus has a significant contribution to ensure assurance of sustainability, efficiency, and compliance. Assists with facilitating and coordinating the daily clinical trial activities and plays an active role in conducting the research studies. Exercises judgment regarding proper patient management, and provides support for the research investigators, faculty, fellows, PCII, and grants administrators.  

Job Duties:

• Research Operations – Study Visits 20% 
  • Develops recruitment strategies, plans, and tools. Engages the community, physicians, and identifies barriers to recruitment.
  • Screens participants independently and provides oversight and training to study team members who screen participants.
  • Maintains subject level documentation for all studies independently. Train others on Good Clinical Practice guidelines related to study documentation.
  • Independently conducts study visits and may perform complex research assessments. Extracts complex data from electronic medical records. May train others to conduct study visits and perform protocol specific testing/interviews.
  • Conducts and/or documents consent for participants in a variety of studies independently. Applies knowledge of human subjects' protection regulations in the informed consent process.
• Research Operations – Regulatory 10%
  • 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.
  • Ensures studies are carried out according to Code of Federal Regulations, Good Clinical Practices, and MUSC policies. Maintains accurate study registration (Clinicaltrials.gov, etc.). Maintains accurate study registration (Clinicaltrials.gov, etc.).
• Research Operations – Administration 10%
  • Provides direction to study teams with preparation for study monitoring and study audit visits. Implements corrective action plans, including re-training of staff as needed. Serves as an expert resource when addressing and correcting findings.
  • Collects, prepares or processes adverse events under supervision.
  • Provides input on safety reports and submits reportable events to the IRB and/or Sponsor under minimal supervision.
  • Reviews study participant charges in the medical record and ensures the route according to the Study Billing Plan.
•  Data and Informatics 10%
  • Uses EDC systems to enter data independently and train others on these tasks. Detects issues related to data, capture, collection or management and suggests solutions.
  • Creates and develops simple to complex databases using research methodology knowledge.
  • Creates and implements data quality control procedures (data management plan, CRF Completion guidelines, risk-based data monitoring, etc.). Identifies trends, outliers, and discrepancies in the data and implements corrective action plans. Provides training to other research staff on data coordination and management.
• Scientific Concepts and Research Design 10%
  • Performs literature reviews independently.
  • Participates in the grant development or research proposal process under direct supervision of the PI.
  • Assists with identifying the various stakeholders to ensure adequate design, implementation, and testing o