This position will support the faculty, residents, and fellows of the Department of Orthopaedic Surgery’s Division of Fibrodysplasia Ossificans Progressiva (FOP) subspecialty in the preparation for, conduct of, and completion of any and all Human Subjects Research projects in which they are engaged. This position will report administratively to the Director of Clinical Research for Orthopaedic Surgery through appropriate Project Managers and will report, on a study-specific basis to the respective principal investigators. The CRC will also work on Department level research initiatives as required.
The ideal candidate has the duty to understand the role of the CRC as the intersection of study execution, customer service, subject safety, and overall compliance in clinical research. To this end, the proper candidate will be expected to have an understanding of clinical research regulations and operations from experience in and exposure to clinical research. The specific duties will be dependent on the protocols assigned and will include, but not be limited to, subject recruitment and enrollment, data capture and management, maintaining site files and inventory, reporting to sponsors and IRB as well as other regulatory bodies, and preparing for and assisting in conducting and documenting subject visits, both remote and at the site.
Due to the potential for patient safety and/or deadline driven issues, communication and/or extended work outside the posted hours is expected as needed. Some studies may require on-call activity, working outside normal hours, some travel, exposure to radioactive materials, pharmaceuticals, working with blood or other human specimens, occasional lifting/stooping, and walking between hospital locations. Some studies may require work with children or the elderly and may require additional background checks either at hire or later.
Internal Number: 38874
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