Clinical Coordinator A: Participate in and coordinate clinical trials within the Penn Department of Medicine Clinical Trials Unit. The person will support a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities. Involvement in trials will range from consulting to serving as the primary coordinator for a study handling all coordinator activities such as:
Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions. Communicate with study team members. Recruit, consent, and screen patients according to protocol. 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, includes 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 and maintenance of study specific case report forms and source document tools. Show vigilance in patient safety, protocol compliance, and data qualify. Adhere to all University of Pennsylvania, FDA, and GCP guidelines.
Clinical Coordinator B, in addition to the above, will develop study specific source documents and trackers, prepare and submit regulatory packages, correspond with sponsor & regulatory review boards, and help with study start-up activities. The CRC B will have less supervision in the management of clinical trials and will need to use more independent judgment.
Clinical Research Coordinator C is expected to perform the duties above with more limited supervision from the project manager. In addition, will develop complex documents such as protocols and consents, lead team meetings, and may take a lead role in study communication with internal and external groups. Work directly with investigators to design, set-up and execute studies. Accountable for making sure study timelines and goals are met. Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required. Management of clinical trials and will need to use more independent judgment.