Clinical Research Coordinator is required to manage multiple trials and supervise clinical research coordinators, research assistants and research students/interns for the Department of Neurosurgery at HUP with PPMC cross coverage. The primary focus will be Intensive Care Unit and Tissue Bank protocols.
Responsibilities will include clinical, regulatory and budgetary and managerial duties: 1. Clinical Trial Management- obtaining patient consent, subject scheduling, abstraction of medical information from charts into online databases Review case report forms with research nurse coordinating the clinical trial on an ongoing basis and makes corrections as needed. Clinical data entry for specific NCRD studies. Organize and collect specimens and transport. Assists in packing and sending specimens to contract laboratory services. Tracks delivery and receipt. Administering questionnaires, personality tests, quality of life assessments or other surveys or inventories. Assists with screening & enrollment procedures. Guides subjects to various departments for tests and procedures. Performs telephone follow-up procedures 2. Regulatory- preparation, submission and monitoring of human subjects protocols, and progress reports. Maintains and keeps records of credentials. Maintains active credentials in BCLS, JCAHO, HJPPA, UPHS Patient Oriented Research Certification Program, Patient Safety Program and all mandatory requirements.. Within 12 months of employment will become SOCRA certified. Prepares for monitoring visits by the Sponsor, FDA or any governing regulatory agency (internal or external) scheduled to review the clinical research trials of the NCRD. Communicates in a timely manner all serious Adverse Events verbally/written to study sponsors and the IRB. Participates in investigator/coordinator meetings, site evaluation, site initiation, and protocol closure visits. 3. Budgetary- developing clinical trial budgets, communicating with hospital and vendors for quotes for services. 4. Manage two clinical research coordinators and research assistants, as well as 10 summer students/interns.
Position is contingent on continued funding.
Internal Number: 44379
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.