Clinical Research Coordinator III

About the Role

The Clinical Research Coordinator III operates under the general direction of the Principal Investigator (PI) or designee, independently performing delegated tasks and procedures involving human subject research. This includes coordination of regulatory activities and management of data for complex research protocols related to treatment, ancillary services, and prevention practices.

Responsibilities

• Obtain consent of research participants in accordance with IRB-approved protocols and all applicable regulations, including HIPAA.
• Assist with recruiting, screening, selecting, maintaining, and terminating study subjects for multiple protocols.
• Identify, schedule, and/or conduct participant study visits, tests, and/or interviews/telephone follow-up calls.
• Ensure accuracy and completion of all regulatory documentation, including local or central IRB and study data. Provide data/support to study investigators, sponsors, and/or external monitors/auditors.
• Direct the activities of research support staff and assist with their training.
• Develop preliminary designs for study-related documentation and data collection tools (e.g., questionnaires, treatment data, and/or therapeutic checklists).
• Contribute to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations, and Institutional Review Board (IRB) processes.
• Assist with financial/operational aspects of grants and contracts. Responsible for clinical research billing review within the required timeframe.
• Conduct preliminary quality assurance reviews of study data.
• Present study status reports related to assigned research projects.
• Track and maintain study-related information in the data management system within the required timeframe.
• Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs.
• Monitor the inventory of research-related supplies.
• Document and collect data/samples for research-related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol.
• Monitor strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local, and institutional guidelines. Identify and resolve issues with protocol compliance. Keep the principal investigator and manager aware of any compliance issues.
• Comply with all safety and infection control standards appropriate to this position.
• Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices.
• Perform other duties as required.

Requirements

• Bachelor’s degree in a scientific or health-related field, or equivalent experience.
• 3-5 years of related experience.
• Ability to travel to off-site locations.