Provides general support for clinical trials coordinated within the unit
Supports and interacts with clinical research coordinators (CRCs) and clinical research nurse (CRNs)
Assists in identifying routine potential problems and communicates with appropriate member of the research team
Attends study related meetings and conferences calls
Assists Investigators with publications and presentations
Assists in obtaining appropriate signatures for regulatory forms
Assists in the preparation of documents needed for initiation, monitoring and close-out visits with sponsors and/or clinical research organization; includes clerical support, copying, gathering information
Organizes and maintains documentation, case report forms and study binders required by sponsor or Clinical Research Organization (CRO) as directed by Supervisor, CRN, or CRC
Obtains records required to complete case report forms
Assist study teams with data entry and data query resolution
Assists in preparation and submission of regulatory documents (including continuing review, amendments, and adverse event reporting) to the University of Pennsylvania Institutional Review Board; includes making copies per IRB requirements and delivery of documents to the IRB
Maintains telephone follow-up with all study patients as dictated by protocol in a timely manner
Reports and maintains documentation of all follow-up calls in source documents/database as designated in the protocol
Assists in email and other clerical duties as requested by CRC, CRN, or Supervisor
Screens for potential patients for research studies and collaborates and confers with PI, clinical research nurse or clinical research coordinator for final approval of the potential patient as a candidate for the study
Prepare study related research lab kits
Coordinate research specimen collection and delivery
Processes and ships blood, urine, and serum specimens for clinical trials
Assists in hospital and campus pick-ups and deliveries
Assists in resolving regulatory related queries with, IRB, CRO and sponsors
Perform additional duties as needed/assigned