Screen, recruit, and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants across infectious disease and gene therapy protocols.
Coordinator B: Participate in and coordinate clinical trials within the Penn Division of Infectious Disease Clinical Trials Unit, consisting of projects in HIV and other Infectious Diseases. The person will support Infectious Disease Investigators in
clinical research ranging from observational trials to investigational product trials, including both investigator-initiated and industry-initiated trials. Work requires on-site presence and interaction with research subjects. Coordinator duties include:
Assist in development of study documents. Communicate with study team members and regulatory review boards. Recruit, consent, and screen patients according to protocol (including specialized gene therapy protocols). Schedule patient visits
and any necessary testing. Conduct patient visits. Monitor patients per protocol requirements and ensure adherence to protocol requirements. Organize and maintain all documentation required by the Investigator, sponsor, or CRO, including
source documentation, case report forms, and research charts. Collect, review, and report study data. Complete case report forms and resolve data queries. Process and ship study specimens including blood and urine. Participate in initiation, monitoring, audit, and close-out visits. Participate in study team meetings and ongoing protocol training. Assist in the development/maintenance of study-specific case report forms and source document tools. Show vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, FDA, and GCP guidelines.
Coordinator C: The Clinical Research Coordinator C is expected to perform the duties above with more limited supervision from the program manager. In addition, will develop complex documents such as protocols and consents (specifically