Position Type : Full Time

Duties:

The Clinical Research Coordinator B will be expected to understand the full complement of duties typically assigned to Clinical Research Coordinators at Penn and elsewhere and to execute these tasks as needed in service to the Department of Orthopaedic Surgery, specifically, the Rare Disease Division of Fibrodysplasia Ossificans Progressiva (FOP). These duties include but are not limited to (1) writing, editing, and submitting study documents such as protocols, summaries, Informed Consent Forms (ICFs) and similar documents for faculty initiated studies, and submitting to the IRB and applicable committees according to the requirements of each reviewing body, (2) developing appropriate de novo study specific documents and study tools to enable the proper and compliant execution of investigator initiated studies including but not limited to Case Report Forms and completion guidelines, operations manuals, data management plans, standard operational procedures, workflow processes and similar (3) performing all site-specific activities associated with either faculty initiated or extramurally funded studies to ensure study and site compliance with applicable regulations and policies, whether Penn is or is not the lead study site (4) Ensuring study progress and patient safety by actively engaging the faculty through the clinic and other mechanisms to identify and enroll applicable subjects and performing all necessary activities associated with study maintenance including venipuncture, and specimen processing, and any and all protocol related functions, (5) becoming an integral part of the overall Human Subjects Research Program at the Division and Departmental levels, (6) train and oversee other staff, residents, or students as applicable in the conduct of human subjects research as needed, (7) taking initiative to observe and continuously satisfy patient needs and improve team knowledge, compliance, practices and processes applicable to human subjects research and (8) other duties as needed. Travel may be required. The Department of Orthopaedic Surgery FOP Division is actively engaged in collaborative studies with other institutions and with industry partners. The Clinical Research Coordinator will be expected to be comfortably familiar with internal and external partners and to interact with them appropriately to advance the research goals of the Department, the Division, and collaborative partners.