courtesy of Julia Douvas '23
Job Summary
The Clinical Research Coordinator I will work with Brynn Marks, MD, MSHPEd and her team. Dr. Marks’ research focus is on type 1 diabetes and developing innovative approaches to improve the clinical implementation of the latest technologies including continuous glucose monitors and automated insulin delivery systems. Her current NIH funding is supporting the development of app-based educational programming for parents of children with type 1 diabetes. She also works to apply diabetes technologies to cystic fibrosis related diabetes screening and care. This role will support her research program, which includes investigator initiated and industry funded studies, with substantial coordination level support for all clinical research activities.
Job Functions
Essential Functions
Core responsibilities
• Adhere to an IRB approved protocol
• Participate in the informed consent process of study subjects
• Support the safety of clinical research patients/research participants
• Coordinate protocol related research procedures, study visits, and follow-up care
• Screen, recruit and enroll patients/research participants
• Maintain study source documents
• Under the supervision of PI Report adverse events
• Understand good clinical practice (GCP) and regulatory compliance
• Educate subjects and family on protocol, study intervention, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines, and wit
HIPAA and management of confidential materials
• Must comply with federal, state, and sponsor policies
• For multi-site studies or collaborations, support communication and meeting scheduling across teams
Related responsibilities
• Manage essential regulatory documents
• Register study on ClinicalTrials.gov as appropriate
• Complete case report forms (paper & electronic data capture) and address queries
• Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie,DSMB, independent safety officer)
• Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
• Facilitate study close out activities as appropriate
• Coordinate research/project team meetings
• Collect, process and ship samples as applicable to the protocol
• Schedule subject visits and procedures
• Retain records/archive documents after study close out