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Posted Job Title
Clinical Research Coordinator B/C
Job Profile Title
Clinical Research Coordinator B
Job Description Summary
As part of the Department of Medicine, the DOM Clinical Trials Unit supports 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. Research coordinator work includes study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Our projects occur throughout the Department of Medicine including Cardiology, Pulmonary, Rheumatology, Translational Medicine, Gastroenterology, Infectious Disease, General Medicine, Sleep, HemOnc, Endocrine, Renal and Geriatrics. To learn more about DOM CTU visit https://www.med.upenn.edu/pennctu/.
Coordinator B:Â Participate in and coordinate clinical trials within the Penn Department of Medicineâ™s Clinical Trials Unit. Â 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.Â Collect, review and report study data.Â Complete case report forms and resolve data queries.Â Process and ship study specimens including blood and urine.Â Participate in initiation, monitoring, audit and close-out visits.Â Participate in study team meetings, and ongoing protocol training.Â Assist in the development/maintenance of study specific case report forms and source document tools.Â Show vigilance in patient safety, protocol compliance and data qualify.Â 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. Â Work directly with investigators to design, set-up and execute studies. Â Accountable for making sure study timelines and goals are met.Â Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required. Â Â Management of clinical trials and will need to use more independent judgment.
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
Coordinator B:Â Bachelorâ™s degree required and 2-4 years of related experience (or equivalent combination of education and experience)
Coordinator C: Bachelorâ™s degree required and 4+ years of related experience (or equivalent combination of education and experience)
Job Location - City, State
Department / School
Perelman School of Medicine
$42,953.00 - $77,315.00
Affirmative Action Statement Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
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.
Internal Number: JR00012124
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.