UNIV - Program Coordinator I - Journeyman - Pediatrics: PRG

Responsibilities

• Research Operations- Patient Visits: 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.
• Site and Study Management: 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: Creates and maintains 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: 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: 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. Works 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. Orders supplies as needed to continue the study.
• Research Operations - Regulatory: Completes IRB and/or Sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.

Qualifications

• A bachelor's degree and two years of relevant program experience.