Clinical Researcher Coordinator B​/C

Clinical Researcher Coordinator B/C

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Clinical Researcher Coordinator B/C

Clinical Research Coordinator B

As part of the Infectious Disease Clinical Trials Group, this position will coordinate clinical research 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. Prior experience in gene therapy clinical trials is ideal but not required. Work requires on-site presence and interaction with research subjects.

Research coordinator work includes study implementation, document development, submission to regulatory boards, subject recruitment and enrollment, study visits, and regulatory compliance in one or more studies.

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 withinthe Penn Division of Infectious Disease Clinical Trials Unit,consisting of projects in HIV and other Infectious Diseases. Theperson will support Infectious Disease Investigators in clinical research ranging from observational trials toinvestigational 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 studyteam 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 formsand 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 ofstudy-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 GCPguidelines.

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 suchas protocols and consents (specifically incorporating gene therapy workflows and endpoints), lead team meetings, and may take a lead role in study communication with internal and external groups. Work directly with investigators todesign, set-up, and execute…