UNIV - Program Coordinator II - Journey - Pediatrics: PRG

This position is for a Program Coordinator II that is under the direction of the Program Manger assuming responsibility and accountability in providing management of study related procedures for patients enrolled in phase I-IV clinical trials. 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 Salary Pay Grade University-GEN
09 Pay Range 53,142.

- 90,372.000 Scheduled Weekly Hours 40 Work Shift

This position is responsible for coordinating and managing clinical trials, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.

• Completing required submissions to the Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC).
• Working alongside the program manager and other internal departments to review budgets and contracts.
• Scheduling and conducting study visits and assessments per protocol; including but not limited to medical history, survey administration, ediary device training, ECGs, concomitant medication, etc.
• Collecting, processing, shipping, and maintaining inventory of research biological specimens
• Ensuring timely and accurate data collection following GCP and ALCOA++ guidelines
• Collecting and reporting adverse events information as required per protocol
• Maintaining screening, study visits, training and consent logs in the Investigator site files.
• Preparing study documentation for routine monitoring visits.
• Serving as the primary liaison between site staff, sponsors, study vendors and other internal departments involved in the conduct of clinical research
• Providing mentorship to junior staff members with areas of training and development.
• Serve as expert resource for hospital staff performing study related procedures.
• Update and maintain internal CTMS systems and review EPIC billing charges.
• Work alongside internal departments to confirm study-related charges and invoiceable items.

• Research Visits: 35%
• Recruitment:
  Synthesizes and interprets recruitment reports to assess effectiveness of recruitment strategies and implements innovative solutions to maximize recruitment strategies by allocating resources appropriately.
• Screening:
  Provides oversight and training to entire team unit with regards to subject screening.
• Establishes systems and policies related to subject screening.
• Study visit preparation and documentation:
  Provides oversight and training to study team members, including clinic staff, regarding preparation of study visits, maintenance of subject level documentation and creation of study level SOPs.
• Conduct study visits:
  Serves as a departmental/unit resource and/or trains others regarding the conduct of study visits, creation of study level SOPs and/or implementation of operational plans.
• May perform advanced clinical assessments or interventions and/or trains others on study assessments.
• Specimen collections:
  Creates, optimizes, and oversees systems to collect, prepare, ship, and maintain inventory of research specimens and trains others on these tasks.
• Informed consent:
  Provides oversight (to include review) to study team members who conduct and document consent for participants in a variety of studies.
• Serves as an expert resource and trainer across department or unit on the consent process and related documentation.
• Investigational Products:
  Responsible for the management of IP. Oversees and serves as an expert resource for study teams on the implementation of and compliance with required systems for IP handling, dispensing and documentation.
• Regulatory management:
  Responsible for creating and/or implementing…