CLINICAL RESEARCH COORD B/C
Duties: Participate in all phases of clinical research, including study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies within the Penn Department of Medicine's newly created Clinical Trials Unit. Studies may be investigator-initiated or industry-sponsored Phase I-IV trials, including gene therapy clinical trials.
Clinical Research Coordinator B: Participate in and coordinate clinical trials within the Penn Department of Medicine's newly created 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. Communicate with study team members and regulatory review boards. 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/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.
The 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.
Position is contingent on continued funding.
Qualifications: Clinical Research Coordinator B: Bachelor's degree and 2-4 years of related experience, or equivalent combination of education and experience, required
Clinical Research Coordinator C: Bachelor's degree and 4+ years of related experience, or equivalent combination of education and experience, required
Both positions: Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations; prior experience in gene therapy trials preferred.
Reference Number: 40-27911
Salary Grade: 026/027
Employment Type: Exempt
Org: DM-Department of Medicine
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: I-Technical/Professional Research